Medical Devices
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December 2009 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
PMA Original Approvals
None.
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790017/S102 12/30/09 180-Day |
Gruntzig Dilaca Balloon Dilatation Catheters | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a sterilization site located at Isotron Ireland Ltd., Offaly, Ireland. |
| P790018/S051 12/18/09 Special |
Hall Easy-Fit® Prosthetic Heart Valve | Medtronic Cardiac Surgery Minneapolis, MN 55432 |
Approval for labeling changes. |
| P830055/S112 12/8/09 Special |
LCS® Total Knee System – P.F.C. Sigma RPF Femoral Components | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for additional in-process dimensional inspections of the P.F.C. Sigma RPF Femoral Components. |
| P840001/S117 12/4/09 135-Day |
Synergy® Family of Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for Multi-Beam Contact (MBC) related manufacturing process changes. |
| P860004/S116 12/4/09 Special |
SynchroMed II Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for labeling changes to the sterile package, shelf box label and implant manual to reflect a new warning which states “Warning: Keep away from magnets.” |
| P860019/S242 12/4/09 Real-Time |
Apex PTCA Dilation Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a change in material of the markerband to a Platinum/ Iridium alloy. |
| P860057/S053 12/8/09 Real-Time |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Theon Pericardial Bioprosthesis, RSR Pericardial Bioprosthesis, and Theon RSR Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for harmonizing the central hole diameter, harmonizing the wireform cusp diameter and adding aortic commissure tip angle and commissure tip radius inspections. |
| P860057/S055 12/11/09 180-Day |
Carpentier-Edwards® PERIMOUNT® Bioprosthesis Heart Valves | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for a manufacturing site located at Singapore Pte. Ltd., Singapore, China. |
| P870024/S047 12/11/09 180-Day |
FluoroPerm® 92 (paflufocon A), FluoroPerm®60 (paflufocon B), Paragon HDS® (paflufocon B), Paragon CRT® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D), Paragon CRT ® 100 (paflufocon D), and Paragon RG-4™ (paflufocon D) Rigid Gas Permeable Contact Lenses |
Paragon Vision Sciences Mesa, AZ 85204 |
Approval for packaging the contact lenses in a different multipurpose solution when shipped wet. |
| P950020/S036 12/28/09 180-Day |
Flextome® Cutting Balloon® | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Boston Scientific Ireland, Ltd., Galway, Ireland. |
| P950021/S009 12/3/09 Real-Time |
Advia Centaur and Advia Centaur CP PSA Immunoassay | Siemens Healthcare Diagnostics Walpole, MA 02032 |
Approval for the change in antibody growth manufacturing process from ascites fluid to cell culture. |
| P950032/S054 12/29/09 Real-Time |
Apligraf (Graftskin) | Organogenesis, Inc. Canton, MA 02021 |
Approval for a new cell strain, HEP 066, for introduction into production of Apligraf. |
| P960009/S054 12/4/09 135-Day |
Kinetra® Therapy of DBS™ | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for Multi-Beam Contact (MBC) related manufacturing process changes. |
| P960040/S211 12/23/09 Special |
Teligen ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for a labeling change to include a warning against sub pectoral device implantation. |
| P970051/S052 12/10/09 135-Day |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for a number of manufacturing changes to include: 1) cosmetic changes to improve the adhesion of the paint to the battery can; 2) housing changes to improve the durability of the battery and to increase the strength of the can; and 3) changes in the welding process to improve ultrasonic weld strength and to reduce weld failures. |
| P990025/S022 12/14/09 Real-Time |
NaviStar (4mm, DS, ThermoCool and RMT) | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the catheter IFUs to allow for additional compatibility with the CARTO 3 systems. |
| P990055/S010 12/3/09 Real-Time |
Advia Centaur Complexed (CPSA) and Advia Centaur CP CPSA Immunoassay | Siemens Healthcare Diagnostics Walpole, MA 02032 |
Approval for the change in antibody growth manufacturing process from ascites fluid to cell culture. |
| P990056/S010 12/3/09 135-Day |
Elecsys Total PSA Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Approval for the introduction of a larger test kit with 200 determinations instead of 100 determinations. |
| P000057/S005 12/4/09 180-Day |
Ascension MCP, Finger-joint, Semi-constrained, Uncemented Prosthesis | Ascension Orthopedics, Inc. Austin, TX 78754 |
Approval of the post-approval study protocol. |
| P010012/S228 12/23/09 Special |
Cognis CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for a labeling change to include a warning against sub pectoral device implantation. |
| P010015/S071 12/7/09 135-Day |
InSync CRT-P and InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Approval for replacing obsolete equipment with new equipment. |
| P010025/S017 12/23/09 Real-Time |
Selenia Dimensions 2D Mobile Full Field Digital Mammography System | Hologic, Inc. Danbury, CT 06810 |
Approval for the Selenia Dimension 2D FFDM to be used in a mobile environment with the following design changes: 1) Acquisition Station: a) The acquisition station monitor will be mounted on a fixed mount mechanism that allows positioning of the monitor via a spring loaded locking device. The mobile system monitor can be fixed mounted on the left, right or center position. b) The keyboard tray has been secured with a spring loaded latching mechanism to prevent movement during transport. c) The bar code scanner can be mounted either on the left or right side of the monitor as needed in the mobile application. d) The x-ray shield is replaced with non attenuating, cosmetic clear plastic (as cover gap fillers). 2) Gantry: a) The vertical travel assembly (VTA) has been configured with an electromagnetic brake to prevent unwanted travel during transport. b) A mounting feature has been added to the top section of the gantry frame for supplemental support in a coach/van. c) The upper movement limit of the C-Arm is now configurable from 6' 10" to 7' 10" to allow for lower ceilings in a coach/van. 3) Instructions for Use and QC Manual: A mobile addendum includes current User Manual with added warnings and instructions regarding mobile use. In addition, the mobile addendum includes instructions to the user on the QC tests that are required to be performed prior to clinical use after movement. |
| P010030/S013 12/16/09 Real-Time |
LifeVest® Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval for a minor software change ot the model WCD 3100 Monitor. |
| P010030/S015 12/16/09 Real-Time |
LifeVest® WCD | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval of an alternate Flash/SRAM chip for use on the WCD 3100, a correction of a Bill of Materials error on the WCD 3100 Computer/Analog printed circuit assembly, and two design changes to the high voltage converter circuit on the defibrillator printed circuit assembly. |
| P010030/S018 12/17/09 Real-Time |
LifeVest® WCD | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval of a construction change affecting the layer stack up within the response buttons. |
| P010052/S004 12/16/09 180-Day |
IMMULITE/ IMMULITE 1000 and IMMULITE 2000 Anti HBs Assay |
Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 |
Approval for IMMULITE/ IMMULITE 1000 and IMMULITE 2000 Anti HBs assay. The device is indicated for: IMMULITE/ IMMULITE 1000 For in vitro diagnostic use with the IMMULITE or IMMULITE 1000 Analyzers for the qualitative and quantitative measurement of total antibodies to the hepatitis B surface antigen (anti-HBs) in human serum and plasma (heparinized). Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. IMMULITE 2000 For in vitro diagnostic use with the IMMULITE 2000 Systems automated immunoassay analyzers for the qualitative and quantitative measurement of total antibodies to the hepatitis B surface antigen (anti-HBs) in human serum and plasma (heparinized). Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following I-IBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. |
| P010068/S018 12/14/09 Real-Time |
NaviStar (4mm, DS, ThermoCool and RMT) | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the catheter IFUs to allow for additional compatibility with the CARTO 3 systems. |
| P020008/S002 12/23/09 Real-Time |
Karl Storz Autofluorescence System | Karl Storz Endoscopy-America, Inc. El Segundo, CA 90245 |
Approval for replacement of the Karl Storz Camera Control Unit (CCU), Tricam SL (Analog processing) with the Tricam SL II (digital signal processing). |
| P030009/S037 12/30/09 180-Day |
Driver and MicroDriver Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a sterilization site located at Isotron Ireland Ltd., Offaly, Ireland. |
| P030031/S019 12/7/09 Real-Time |
Celsius RMT ThermoCool Diagnostic/Ablation Deflectable Tip Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for design modifications removing CARTO RMT connectivity from the NaviStar RMT Thermocool catheter handle, resulting in the Celsius RMT Thermocool catheter. |
| P030031/S021 12/14/09 Real-Time |
EZ Steer (4mm and DS) Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the catheter IFUs to allow for additional compatibility with the CARTO 3 systems. |
| P030039/S014 12/18/09 Real-Time |
CoSeal® Surgical Sealant | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Approval for a change in the materials used to make the syringe that holds the polyethylene glycol (PIG) polymers. |
| P030050/S006 12/2/09 Real-Time |
Sculptra | Sanofi-Aventis U.S., LLC Bridgewater, NJ 08807 |
Approval for revision of the Sculptra physician and patient labeling. |
| P040003/S006 12/22/09 180-Day |
ExAblate 2100 System | InSightec, Inc. Dallas, TX 75244 |
Approval for addition of enhanced sonication, a detachable cradle, and several other modifications to the ExAblate 2000 system. The device, as modified, will be marketed under the trade name ExAblate 2100 and is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure and whose uterine size is less than 24 weeks. Patients should have completed child bearing. |
| P040033/S013 12/31/09 135-Day |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Memphis, TN 38116 |
Approval for a change to new testing equipment used for measuring surface finish, tape angle, and diameter for the R3 metal liners. |
| P040033/S014 12/11/09 Special |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Memphis, TN 38116 |
Approval for revisions to the physician and patient labeling. |
| P040034/S014 12/8/09 Real-Time |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham, MA 02451 |
Approval for labeling changes to the DuraSeal “Instructions for Use” insert and an update to the graphics found on the polymer kit’s Tyvek lid. |
| P040036/S014 12/14/09 Real-Time |
NaviStar (4mm, DS, ThermoCool and RMT) | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the catheter IFUs to allow for additional compatibility with the CARTO 3 systems. |
| P040037/S022 12/14/09 135-Day |
Gore Viabahn® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for an alternate supplier. |
| P040044/S021 12/11/09 Real-Time |
Mynx® Vascular Closure Device | Acces Closure, Inc. Mountain View, CA 94043 |
Approval for changes to the catheter hub barrel and compression spring located inside the Mynx handle. |
| P050016/S005 12/3/09 Special |
Cormet Hip Resurfacing System | Corin U.S.A. Tampa, FL 33612 |
Approval for labeling changes to the package insert and patient brochure to include two additional potential adverse effects, pseudotumours and Avascular Lymphocyte Dominated Vasculitis Associated Lesions (ALVAL) as well as an additional precaution that the subject device has not been tested in the Magnetic Resonance (MR) environment. |
| P050016/S006 12/31/09 Real-Time |
Cormet Hip Resurfacing System | Corin U.S.A. Tampa, FL 33612 |
Approval for a change to the method of sterilization of the Individually Packaged Fluted Guide Wire and revisions to the package labeling. |
| P050047/S010 12/29/09 135-Day |
Juve'derm® Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Approval for an additional supplier. |
| P060010/S008 12/9/09 Real-Time |
The Spanner™ Temporary Prostatic Stent | Experien Group, LLC Sunnyvale, CA 94089 |
Approval for changes to the design of the distal anchor including molding the anchor flat, replacing the wire reinforcement with an increase in durometer of the silicone, and adding Titanium Dioxide as a white colorant. |
| P060039/S008 12/22/09 180-Day |
Attain StarFix Lead | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval of the post-approval study protocol. |
| P060040/S004 12/4/09 180-Day |
Thoratec HeartMate II® Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Approval for a new sealed (Gelweave™) outflow graft with bend relief for use with the HeartMate II LVAS. |
| P070014/S006 12/8/09 Special |
LifeStent and LifeStent XL Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Approval for the proposed change in product labeling that affects the Stent Deployment Procedures within the Instructions for Use. |
| P070015/S022 12/7/09 135-Day |
XIENCE V® and PROMUS® Everolimus Eluting Coronary stent Systems | Abbott Vascular Temecula, CA 92590 |
Approval to modify an in-process specification. |
| P080013/S002 12/10/09 Real-Time |
DuraSeal® Spine Sealant System | Covidien Waltham, MA 02451 |
Approval to identify alternate applicators and kit configurations for the DuraSeal® Spine Sealant System. |
| P080023/S001 12/10/09 180-Day |
ARCHITECT® CORE™ Reagent Kit | Abbott Laboratories Abbott Park, IL 60064 |
Approval for migration of the ARCHITECT® CORE™ assay to a new ARCHITECT® i System family member, the ARCHITECT® i 1000 SR. The ARCHITECT"1 CORE™ Reagent Kit device is indicated for: The ARCHITECT® CORE™ assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti-HBc) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790017/S103 12/15/09 |
Gruntzig Dilaca Balloon Dilatation Catheters | Medtronic Vascular Santa Rosa, CA 95403 |
Change in biological indicator storage times. |
| P830055/S113 12/22/09 |
LCS® Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Packaging material change. |
| P840039/S059 12/2/09 |
Polymethylmetha-crylate (PMMA) Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the biological indicator testing site from Alliance Medical Products in Irvine, California to the Bausch & Lomb facility in Tampa, Florida. |
| P860019/S244 12/4/09 |
PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an analytical test method. |
| P860019/S245 12/2/09 |
PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the Fourier-Transform Infrared Spectroscopy (FTIR) Method. |
| P860019/S246 12/17/09 |
PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a vacuum loader to the manufacturing process. |
| P860047/S023 12/2/09 |
Ocucoat | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the biological indicator testing site from Alliance Medical Products in Irvine, California to the Bausch & Lomb facility in Tampa, Florida. |
| P870056/S036 12/30/09 |
Carpentier-Edwards Porcine Bioprosthesis & Carpentier-Edwards Bioprosthetic Valved Conduit | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of alternate material suppliers. |
| P870077/S033 12/30/09 |
Carpentier-Edwards Duraflex Mitral Low Pressure Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of alternate material suppliers. |
| P880003/S099 12/11/09 |
DURASTAR™ Rx PTCA Balloon Dilation Catheter and FIRESTAR™ Rx PTCA Balloon Dilation Catheter | Cordis Corporation Miami Lakes, FL 33014 |
Modification to the catheter tip cutting operation. |
| P880086/S182 12/16/09 |
Affinity/Integrity/ Victory/Accent Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate supplier for the RF electronic assembly module. |
| P880090/S027 12/2/09 |
Polymethylmetha-crylate (PMMA) Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the biological indicator testing site from Alliance Medical Products in Irvine, California to the Bausch & Lomb facility in Tampa, Florida. |
| P910061/S019 12/2/09 |
Soflex & Sofport Posterior Chamber Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the biological indicator testing site from Alliance Medical Products in Irvine, California to the Bausch & Lomb facility in Tampa, Florida. |
| P920023/S026 12/23/09 |
UroLume® Endoprosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 |
Modification of the rear handle molding equipment and a related in-process test fixture. |
| P930038/S060 12/3/09 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical Maple Grove, MN 55311 |
Alternate vendor to supply bovine collagen. |
| P950032/S055 12/23/09 |
Apligraf® (Grafskin) | Organogenesis, Inc. Canton, MA 02021 |
Addition of an alternate material supplier, HyClone® ( Logan, Utah), for bulk media containing Human (APO) Transferrin which is used in the production bulk media for the processing of Apligraf®. |
| P960009/S072 12/18/09 |
Activa® Deep Brain Stimulation Device | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate distribution site for the device. |
| P960011/S014 12/16/09 |
BD 1% OVD (1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Change in pressure set points during sodium hyaluronate fermentation. |
| P960040/S206 12/14/09 |
Teligen Family of Pacemakers | Boston Scientific St. Paul, MN 55112 |
Change to in-process acceptance testing for specific components. |
| P960040/S207 12/22/09 |
Vitality and Confient | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a Nikon Optical System to the process monitoring step. |
| P960040/S208 12/22/09 |
Teligen family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the lead-frame plating and capacitance tolerance. |
| P960040/S209 12/22/09 |
Teligen® Implantable Cardioverter Defibrillator (ICD) | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of two new acceptance activities to the final inspection at the supplier. |
| P960040/S210 12/22/09 |
Teligen Family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Changes to the following: 1) decontamination step; 2) wetblasting step; and 3) in process monitor for specifications. |
| P960043/S070 12/22/09 |
Perclose® ProGlide™ Suture-Mediated Closure System and Perclose® A·T 6F Suture-Mediated Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Change to a reprocessing manufacturing step. |
| D970003/S114 12/22/09 |
Insignia and Altrua | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a Nikon Optical System to the process monitoring step. |
| P970012/S059 12/22/09 |
Kappa 400 DR & SR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of EtO sterilization and aerator equipment. |
| P970051/S058 12/2/09 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Changes to the manufacturing process for the welding of the internal magnet of the CI500 Series Cochlear Implant. |
| P980016/S212 12/22/09 |
GEM II ICD; Marquis ICD; Maximo ICD; Intrinsic ICD; Entrust ICD; Virtuoso ICD; Maximo II DR ICD; Maximo II VR ICD; Virtuoso II DR; Virtuoso II VR; Secura DR; Secura VR |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of EtO sterilization and aerator equipment. |
| P980016/S213 12/23/09 |
Secura DR/VR; Virtuoso DR/VR ICD; Maximo II DR/VR; Virtuoso II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of Radio Frequency Device Test changes on the Automated Test Equipment application software. |
| P980016/S214 12/30/09 |
InSync Family of ICDs, Concerto Family of CRT-Ds, Maximo II CRT-D, and Consulta CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Change in the mean power parameter for a laser welding manufacturing operation. |
| P980016/S215 12/30/09 |
Secura DR/VR; Maximo II DR/VR; Virtuoso II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Changes to a hybrid test. |
| P980022/S065 12/1/09 |
Paradigm Real-Time Pump and Guardian Real-Time Monitor | Medtronic MiniMed Northridge, CA 91325 |
Minor change to the power inductors used in the Paradigm Real-Time Pump and the Guardian Real-Time Monitor and replacing the supplier of the power inductors. |
| P980035/S148 12/22/09 |
Kappa 600/700, 650, 800/900 IPG; Relia IPG; Medtronic 350 IPG; EnPulse IPG; EnRhythm IPG; AT500 IPG; Adapta/Versa/ Sensia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of EtO sterilization and aerator equipment. |
| P980035/S149 12/22/09 |
Adapta, Versa, Sensia and Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Change in the specification limits and implementation of the RTT Vbatt test block. |
| P980037/S033 12/4/09 |
AngioJet® Rheolytic™ Thrombectomy System | MEDRAD Interventional/ Possis Minneapolis, MN 55433 |
Change form a manual to an automated final packaging process. |
| P980049/S051 12/14/09 |
Ovatio VR and Ovatio DR ICDs | ELA Medical, Inc. Plymouth, MN 55441 |
Change in the location for manufacturing the hybrid electronic module component. |
| P990001/S058 12/22/09 |
Dema IPG; C-Series IPG; T-Series IPG |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of EtO sterilization and aerator equipment. |
| P990020/S038 12/15/09 |
AneuRx AAAdvantage Stent Graft Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to remove a washing process. |
| P990033/S016 12/9/09 |
PepGen P-15 FLOW | Dentsply International York, PA 17405 |
Change of the in-process bioburden specification. |
| P990037/S029 12/2/09 |
Vascular Solutions D-Stat Flowable Hemostat | Vascular Solutions, Inc. Minneapolis, MN 55369 |
Changes to sterilization configuration and capacity. |
| P990040/S010 12/23/09 |
Trufill® N-Butyl Cyanoacrylate (NBCA) Liquid Embolic System | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Adding a new contractor for quality control testing and change in the supply chain. |
| P000007/S022 12/30/09 |
Edwards Prima Plus Stentless Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of alternate material suppliers. |
| P000029/S061 12/10/09 |
Deflux® Injectable Gel | Oceana Therapeutics, Inc. Edison, NJ 08817 |
Changes to the microbiological sampling of the clean room and water in thermal units. |
| P010012/S222 12/14/09 |
COGNIS Family of Pacemakers | Boston Scientific St. Paul, MN 55112 |
Change to in-process acceptance testing for specific components. |
| P010012/S223 12/22/09 |
Livian and Contak Renewal | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a Nikon Optical System to the process monitoring step. |
| P010012/S224 12/22/09 |
ACUITY Spiral Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a component manufacturer. |
| P010012/S225 12/22/09 |
Cognis Family of CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the lead-frame plating and capacitance tolerance. |
| P010012/S226 12/22/09 |
Cognis® Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
Boston Scientific Corporation St. Paul, MN 55112 |
Addition of two new acceptance activities to the final inspection at the supplier. |
| P010012/S227 12/22/09 |
Cognis Family of CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Changes to the following: 1) decontamination step; 2) wetblasting step; and 3) in process monitor for specifications. |
| P010015/S074 12/22/09 |
InSync CRT-P; InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Addition of EtO sterilization and aerator equipment. |
| P010029/S009 12/16/09 |
EUFLEXXA® (1% Sodium Hyaluronate) |
Ferring Pharmaceuticals, Inc. | Change in pressure set points during sodium hyaluronate fermentation. |
| P010029/S011 12/22/09 |
EUFLEXXA® (1% Sodium Hyaluronate) |
Ferring Pharmaceuticals, Inc. | Introduction of an additional piece of equipment for testing in-process control (IPC) and finished product samples. |
| P010030/S017 12/2/09 |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Addition of a contract manufacturer for a unit sub-assembly. |
| P010031/S172 12/22/09 |
InSync ICD; InSync Marquis ICD; InSync II Marquis ICD; InSync Marquis III ICD; InSync II Protect ICD; InSync III Protect ICD; InSync Sentry ICD; InSync Maximo ICD; Concerto CRT-D; Concerto II CRT-D; Maximo II CRT-D; Consulta CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Addition of EtO sterilization and aerator equipment. |
| P010031/S173 12/23/09 |
Concerto CRT-ICD; Consulta CRT-D; Maximo II CRT-D; Concerto II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of Radio Frequency Device Test changes on the Automated Test Equipment application software. |
| P010031/S174 12/30/09 |
Marquis Family of ICDs, Maximo Family of ICDs, Virtuoso Family of ICDs, Secura DR/VR, Intrinsic ICD, and EnTrust ICD | Medtronic, Inc. Mounds View, MN 55112 |
Change in the mean power parameter for a laser welding manufacturing operation. |
| P010031/S175 12/30/09 |
Concerto II; Maximo II and Consulta families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Changes to a hybrid test. |
| P010041/S021 12/30/09 |
Carpentier-Edwards S.A.V Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Addition of alternate material suppliers. |
| P020009/S052 12/4/09 |
Express® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an analytical test method. |
| P020009/S053 12/2/09 |
Express 2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the Fourier-Transform Infrared Spectroscopy (FTIR) Method. |
| P020009/S054 12/2/09 |
Express™ and Express 2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to a step in the Stent Final Inspection work instruction. |
| P020009/S055 12/3/09 |
Express 2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate method for selecting the width measurement program settings. |
| P020022/S009 12/23/09 |
Versant HCV RNA 3.0 Assay (bDNA) | Siemens Healthcare Diagnostics | Elimination of an in-process test step for kit components used in the device. |
| P030005/S059 12/22/09 |
Contak Renewal TR | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a Nikon Optical System to the process monitoring step. |
| P030011/S006 12/23/09 |
CardioWest™ Temporary Total Artificial Heart (TAH-t) System | SynCardia Systems, Inc. Tucson, AZ 85713 |
Addition of a heat treatment step. |
| P030025/S066 12/4/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an analytical test method. |
| P030025/S067 12/2/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the Fourier-Transform Infrared Spectroscopy (FTIR) Method. |
| P030025/S068 12/3/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Update to an analytical test method. |
| P030025/S070 12/4/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Update to an analytical test method. |
| P030025/S071 12/2/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to a step in the Stent Final Inspection work instruction. |
| P030025/S072 12/3/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate method for selecting the width measurement program settings. |
| P030025/S074 12/2/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of duplicate environmental testing. |
| P030025/S075 12/7/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a vacuum loader to the manufacturing process. |
| P030025/S076 12/7/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the frequency of replacement for the acid bath. |
| P030025/S077 12/7/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to a fixture used in the catheter manufacturing process. |
| P030025/S079 12/17/09 |
TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Reduction in the acid washing change out frequency. |
| P030035/S063 12/16/09 |
Frontier/ Frontier II/Anthem Family of CRT-Ps |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate supplier for the RF electronic assembly module. |
| P040016/S039 12/4/09 |
Liberté Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an analytical test method. |
| P040016/S040 12/2/09 |
Liberté Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the Fourier-Transform Infrared Spectroscopy (FTIR) Method. |
| P040016/S041 12/2/09 |
Liberté Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to a step in the Stent Final Inspection work instruction. |
| P040016/S042 12/3/09 |
Liberté Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate method for selecting the width measurement program settings. |
| P040016/S043 12/7/09 |
VeriFLEX™ (Liberté®) Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the frequency of replacement for the acid bath. |
| P040016/S044 12/7/09 |
Liberté Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to a fixture used in the catheter manufacturing process. |
| P040016/S045 12/17/09 |
VeriFLEX™ (Liberté®) Monorail and Over-the-Wire Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a vacuum loader to the manufacturing process. |
| P040016/S046 12/17/09 |
VeriFLEX™ (Liberté®) Monorail and Over-the-Wire Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Reduction in the acid washing change out frequency. |
| P040048/S010 12/8/09 |
Trilogy AB Acetabular System (VerSys Heritage Femoral Stems) | Zimmer, Inc. Warsaw, IN 46581 |
Changes to manufacturing steps and materials used during the manufacture of the VerSys Heritage Femoral Stems. |
| P040048/S012 12/22/09 |
Trilogy AB Acetabular System | Zimmer, Inc. Warsaw, IN 46581 |
Changes in the Ceramic Plasma Spray Environmentally Controlled Area (ECA). |
| P050012/S021 12/4/09 |
DexCom™ SEVEN® Continuous Glucose Monitoring System | DexCom, Inc. San Diego, CA 92121 |
Replacement of paper-based lot history records (LHRs) with electronic LHRs. The change implements Camstar Manufacturing Execution System (MES), an electronic control system for managing and monitoring work-in process on a manufacturing floor. |
| P050047/S011 12/24/09 |
Juvederm Hyaluronate Gel Implants | Allergan | Removal of a retreatment step of a raw material. |
| P060002/S007 12/2/09 |
Bard® Flair® Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Installation of additional manufacturing equipment. |
| P060002/S008 12/15/09 |
Bard® Flair® Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Change in environmental monitoring testing. |
| P060002/S009 12/18/09 |
Bard® Flair® Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Upgrade to process equipment. |
| P060006/S001 12/4/09 |
Express™ SD Renal Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an analytical test method. |
| P060006/S002 12/2/09 |
Express™ SD Renal Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the Fourier-Transform Infrared Spectroscopy (FTIR) Method. |
| P060006/S003 12/2/09 |
Express™ SD Renal Monorail™ Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to a step in the Stent Final Inspection work instruction. |
| P060008/S021 12/4/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an analytical test method. |
| P060008/S022 12/2/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the Fourier-Transform Infrared Spectroscopy (FTIR) Method. |
| P060008/S023 12/3/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Update to an analytical test method. |
| P060008/S025 12/4/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Update to an analytical test method. |
| P060008/S026 12/2/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to a step in the Stent Final Inspection work instruction. |
| P060008/S027 12/3/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate method for selecting the width measurement program settings. |
| P060008/S029 12/2/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of duplicate environmental testing. |
| P060008/S030 12/7/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the frequency of replacement for the acid bath. |
| P060008/S031 12/7/09 |
TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to a fixture used in the catheter manufacturing process. |
| P060008/S032 12/17/09 |
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a vacuum loader to the manufacturing process. |
| P060008/S033 12/17/09 |
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Reduction in the acid washing change out frequency. |
| P060017/S004 12/17/09 |
GeneSearch Breast Lymph Node (BLN) Assay | Veridex, LLC Raritan, NJ 08869 |
Extension of shelf-life of plasmid DNA raw material used in the manufacture of the External Positive and External Negative Controls of the device. |
| P060027/S016 12/14/09 |
Ovatio and Paradym CRT-Ds | ELA Medical, Inc. Plymouth, MN 55441 |
Change in the location for manufacturing the hybrid electronic module component. |
| P070007/S014 12/17/09 |
Medtronic Vascular Talent Thoracic Stent Graft | Medtronic Vascular Santa Rosa, CA 95403 |
Addition of alternate adhesive application equipment and an in-process visual inspection. |
| P070007/S015 12/15/09 |
Talent Thoracic Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to remove a washing process. |
| P070015/S029 12/22/09 |
XIENCE V® Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Change for a protective sheath component. |
| P070027/S013 12/17/09 |
Medtronic Vascular Talent Abdominal Stent Graft | Medtronic Vascular Santa Rosa, CA 95403 |
Addition of alternate adhesive application equipment and an in-process visual inspection. |
| P070027/S014 12/15/09 |
Talent Abdominal Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Change to remove a washing process. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 50
Summary of PMA Originals Under Review
Total Under Review: 78
Total Active: 41
Total On Hold: 37
Number Greater Than 180 Days: 8
Summary of PMA Supplements Under Review
Total Under Review: 555
Total Active: 376
Total On Hold: 179
Number Greater Than 180 Days: 17
Summary of All PMA Submissions Received
Originals: 6
Supplements: 45
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 50
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 128.4
FDA Time: 84.3 Days MFR Time: 44.1 Days
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