Medical Devices
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Listing of CDRH Humanitarian Device Exemptions
| HDE Number Approval Date and Docket Number | Device Name | Company Name and Address | Device Description / Device Indications |
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| H100004 12/16/2011 2011-M-0919 | Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) | Berlin Heart, Inc. | The EXCOR is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR. |
| H090002 11/18/2011 2011-M-0848 | BSD-2000 Hyperthermia System | BSD Medical Corporation | This device is indicated for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors. |
| H100008 11/01/2011 2011-M-0726 | Ovation Abdominal Stent Graft System | TriVascular, Inc. | The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta with small aortic diameters and access vessels of less than 7 mm in diameter, and having vascular morphology suitable for endovascular repair. |
| H100006 09/28/2011 2011-M-0707 | NeuRx DPS™, Diaphragm Pacing System | Synapse Biomedical, Inc. | The NeuRx Diaphragm Pacing System (DPS)™ is a percutaneous, intramuscular, diaphragm motor point stimulating device intended for use in amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm (both right and left portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and who are experiencing chronic hypoventilation (CH) , but not progressed to an FVC less than 45% predicted. For use only in patients 21 years of age or older. |
| H100002 04/01/2011 2011-M-0241 | cPAX Aneurysm Treatment System | NeuroVasx, Inc. | The cPAX Aneurysm Treatment System is indicated for use in the adult population (22 years of age and older) for the treatment of wide-necked large and giant-sized cerebral aneurysms (>10) mm that require use of adjunctive assist-devices such as stents or balloons. |
| H080005 03/10/2011 11M-0170 | Elana Surgical KitHUD | Elana, Inc. | The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large (> 2.5 mm), intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity. |
| H080002 25-Jan-2010 10M-0063 | Medtronic Melody® Transcatheter Pulmonary Valve (Model PB10) and Medtronic Ensemble® Transcatheter Valve Delivery System (NU10) | Medtronic, Inc. | This device is indicated for use as an adjunct to
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| H050003 19-Feb-2009 09M-0090 | Reclaim™ Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD) Therapy | Medtronic Neuromodulation | This device is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). |
| H060002 24-Oct-2008 08M-0579 | IBV® Valve System | Spiration, Inc. | This device is indicated to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV® Valve System use is limited to 6 weeks per prolonged air leak. |
| H040004 10-Oct-2008 08M-0562 | INFUSE/MASTERGRAFT™ Posterolateral Revision Device | Medtronic Sofamor Danek USA, Inc. | This device has been withdrawn at the request of the sponsor effective March 23, 2010. |
| H070004 07-Oct-2008 08M-0563 | Levitronix Centrimag® Right Ventricular Assist System (RVAS) | Levitronix, LLC | This device is indicated for temporary circulatory support for up to 14 days for patients in cardiogenic shock due to acute right ventricular failure. |
| H070003 17-Jun-2008 08M-0378 | NeuRx RA/4 | Synapse Biomedical, Inc. | This device is indicated for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older. |
| H990002 25-Oct-2007 07M-0415 | Epicel® (cultured epidermal autografts) | Genzyme Biosurgery | The device is indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns. |
| H060001 08-May-2007 07M-0190 | ENTERPRISE Vascular Reconstruction Device and Delivery System | Cordis Neurovascular, Inc. | Use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of >= 3 mm and <= 4 mm. Wide-neck is defined as having a neck width >= 4mm or a dome-to-neck ratio < 2. |
| H060003 11-Apr-2007 07M-0156 | Onyx® Liquid Embolic System (Onyx® HD-500, Model 105-8101-500) | EV3 Neurovascular | Treatment of intracranial, saccular, sidewall aneurysms that present with a wide neck (>= 4 mm) or with a dome-to-neck ratio < 2 that are not amenable to treatment with surgical clipping |
| H060004 24-Jan-2007 07M-0038 | Fujirebio Mesomark™ Assay | Fujirebio Diagnostics, Inc. | The Fujirebio Diagnostics, Inc. (FDI) MESOMARK™ is an Enzyme Linked Immunosorbent Assay (ELISA) for the quantitative measurement of Soluble Mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epitheloid or biphasic mesothelioma. MESOMARK™ values must be interpreted in conjunction with all other available clinical laboratory data. |
| H040006 05-Sep-2006 06M-0368 | Abiocor® Implantable Replacement Heart | Abiomed, Inc. | This device is indicated for use in severe biventricular end stage heart disease patients who are not cardiac transplant candidates and who
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| H040005 31-Mar-2006 06M-0163 | Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 or 12 degree scope, and Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degree scope | Karl Storz Endoscopy-America, Inc. | The Karl Storz TTTS Fetoscopy Instruments Sets are indicated for selective laser photocoagulation (S-PLC) in the treatment of twin-to-twin transfusion syndrome (TTTS) for fetuses whose gestational age is between 16 and 26 weeks. |
| H050001 03-Aug-2005 05M-0308 | Wingspan Stent System with Gateway PTA Balloon Catheter | Boston Scientific Smart | This device is indicated for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with greater than or equal to 50% stenosis that are accessible to the system. |
| H030005 30-Mar-2005 05M-0132 | CoAxia NeuroFlo Catheter | CoAxia, Inc. | This device is indicated for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management. |
| H030009 24-Aug-2004 04M-0415 | Vertical Expandable Prosthetic Titanium Rib (VEPTR) | Synthes (USA) | For the treatment of Thoracic Insufficiency Syndrome (TIS) in skeletally immature patients. TIS is defined as the inability of the thorax to support normal respiration or lung growth. For the purpose of identifying potential TIS patients, the categories in which TIS patients fall are as follows: Flail Chest Syndrome
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| H040002 26-Jul-2004 06M-0233 | INTACS® Prescription Inserts for Keratoconus (0.25mm, 0.30mm, and 0.35mm) | Addition Technology | INTACS® prescription inserts are intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for a corneal transplant procedure may potentially be deferred. The specific subset of keratoconic patients proposed to be treated with INTACS® prescription inserts are those patients:
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| H020008 07-Apr-2004 04M-0165 | OP-1 Putty | Stryker Biotech 35 South Street Hopkinton, MA 01748 | For use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes. |
| H030003 25-Feb-2004 04M-0090 | DeBakey VAD Child Left Ventricular Assist System | MicroMed Technology, Inc. | For use to provide temporary left side mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients (5-16 years old, with BSA>= 0.7 m2 and <1.5 m2) who are in NYHA Class IV end stage heart failure, are refractory to medical therapy and who are (listed) candidates for cardiac transplantation. |
| H030004 24-Feb-2004 04M-0084 | Heartsbreath | Menssana Research Inc. 1 Horizon Road Suite 1415 Fort Lee, NJ 07024-6510 USA | For use as an aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. The Heartsbreath test is intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month. |
| H020003 21-Nov-2003 03M-0536 | CONTEGRA Pulmonary Valved Conduit | Medtronic, Inc | The CONTEGRA Pulmonary Valved Conduit is indicated for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in patients aged less than 18 years with any of the following congenital heart malformations:
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| H020004 07-Jul-2003 03M-0305 | Dermagraft | Smith and Nephew Wound Management | This device has been withdrawn by the sponsor as of September 28, 2007. |
| H020007 15-Apr-2003 03M-0157 | Medtronic Activa Dystonia Therapy | Medtronic Neurological | For unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or above |
| H020002 02-Sep-2002 02M-0409 | Neuroform Microdelivery Stent System | SMART Therapeutics, Inc. 2551 Merced St. San Leandro, CA 94577 USA | The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than or equal to 2mm and less than or equal to 4.5mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck of 4mm or a dome-to-neck ratio of <2. |
| H010004 09-Aug-2002 02M-0361 | NEUROLINK® System, including NEUROLINK® Stent & Delivery Catheter and NEUROLINK® Balloon Dilatation Catheter | Guidant Corporation Santa Clara, CA USA | The NEUROLINK® System is indicated for the treatment of patients with recurrent intracranial stroke attributable to atherosclerotic disease refractory to medical therapy in intracranial vessels ranging from 2.5 to 4.5 mm in diameter with > 50% stenosis and that are accessible to the stent system |
| H000007 05-Apr-2002 02M-0167 | Amplatzer® PFO Occluder | AGA Medical Corporation Golden Valley, MN | This document has been withdrawn as of October 31, 2006. For more information, please visit this link. |
| H010005 22-Mar-2002 02M-0121 | Ascension® PIP | Ascension Orthopedics, Inc. Austin, TX | For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patients has soft tissue and bone that can provide adequate stabilization and fixation under high demand loading conditions after reconstruction; and needs a revision of a failed PIP prostheis, or has pain, limited motion, or joint subluxation/dislocation secondary to damage or destruction of the articular cartilage. |
| H000002 19-Dec-2001 02M-0311 | VISX Excimer Laser System and Custom Contoured Ablation Pattern (C-CAP) Method™ | VISX, Inc. | For the treatment of asymmetrical ablation patterns from previous laser refractive surgery caused by decentration of the treatment as viewed on the Zeiss Humphrey® topography unit and treated with the STAR S3 ActiveTrak™ Excimer Laser System in patients:
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| H010002 17-Oct-2001 01M-0482 | OP-1™ Implant | Stryker Biotech Hopkinton, MA | The device is indicated for use as an alternative to autograph in recalcitrant long bone nonunions where use of autograph is unfeasible and alternative treatments have failed. |
| H010001 28-Aug-2001 01M-0392 | Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis | Avanta Orthopaedics, Inc. San Diego, CA | The device is indicated for use in arthroplasty of the MCP joint when either the:
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| H000004 19-Mar-2001 01M-0485 | PROSTALAC Hip Temporary Prosthesis | DePuy Orthopaedics, Inc., a Johnson & Johnson Company | This device is indicated for use as a short-term total hip replacement (THR) in patients who need a two-stage procedure to treat a confirmed infection of their THR and where vancomycin and tobramycin are the most appropriate antibiotics for treatment of the infection based on the susceptibility pattern of the infecting microorganism(s). |
| H990013 21-Feb-2001 01M-0201 | Composite Cultured Skin (CCS) | Ortec International, Inc. New York, NY 10032 | For use in patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB) as an adjunct to standard autograft procedures (i.e., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.e., “mitten” hand deformities). |
| H000001 10-Jan-2001 010M-006 | JOMED JOSTENT® Coronary Stent Graft | JOMED AB | For Use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts > 2.75 mm in diameter. |
| H990012 11-May-2000 00M-1354 | TAS Ecarin Clotting Time Test | Cardiovascular Diagnostics, Inc. | To be used to determine the anticoagulant effect of recombinant hirudin (r-hirudin) during cardiopulmonary bypass in patients who have heparin induced thrombocytopenia (HIT). |
| H990014 31-Mar-2000 00M-1451 | Enterra™ Therapy System (formerly named Gastric Electrical Stimulation (GES) System | Medtronic, Inc. | For the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. |
| H990008 09-Mar-2000 00M-1228 | Telescopic Plate Spacer (TPS) Spinal System | Interpore Cross International | The sponsor has withdrawn this HDE effective Sept. 1, 2010 |
| H990011 01-Feb-2000 00M-0599 | CardioSEAL® Septal Occlusion System | Nitinol Medical Technologies, Inc | This document has been withdrawn as of October 31, 2006. For more information, please visit this link. |
| H980006 10-Dec-1999 99M-5539 | TheraSphere® | MDS Nordion, Inc., Kanata, Ontario, Canada | For radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. |
| H990007 07-Dec-1999 99M-5327 | BioGlue®Surgical Adhesive | CryoLife, Inc. | For use as an adjunct in the surgical repair of acute thoracic aortic dissections. NOTE: This HDE is superseded by PMA P010003. |
| H980007 30-Sep-1999 99M-4810 | Shelhigh Pulmonic Valve Conduit Model NR-4000 with "No-React®" Treatment | Shelhigh, Inc. | For replacement of the diseased, damaged. or absent pulmonic artery in small children or infants up to age 4 years, with Transposition of the Great Arteries, Truncus Arteriosis, Tetrology of Fallot with associated cardiac anomalies or with Pulmonary Atresia, or replacement of failed conduits in young patients with accelerated conduit failure. |
| H990005 28-Sep-1999 99M-4763 | CardioSEAL®Septal Occlusion System | Nitinol Medical Technologies, Inc | For the treatment of patients with complex ventricular septal defects (VSD) of a significant size to warrant closure, but that, based on location, cannot be closed with standard surgical transatrial or transarterial approaches. |
| H990003 20-Sep-1999 99M-4619 | Acticon™Neosphincter | American Medical Systems, Inc. | For the treatment of severe fecal incontinence in post-pubescent males and females who have failed, or are not candidates for, less invasive forms of restorative therapy. |
| H990004 08-Sep-1999 99M-4134 | CardioSEAL® Septal Occlusion System | Nitinol Medical Technologies, Inc. | For the treatment of patients with complex single ventricle physiology who have undergone a fenestrated Fontan palliation procedure and require closure of the fenestration. |
| H980008 19-Feb-1999 99M-0255 | VOCARE® Bladder System | NeuroControl Corporation Valley View, OH 44125 | For the treatment of patients who have clinically complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine. Secondary intended use is to aid in bowel evacuation |
| H980005 28-Dec-1998 99M-0150 | VOCARE® Bladder System | NeuroControl Corp. Valley View, OH 44125 | For the treatment of patients who have clinically complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine. |
| H980002 28-Sep-1998 98M-0895 | Avanta Proximal Interphalangeal (PIP) Finger Prosthesis | Avanta Orthopaedics, Inc | For use in arthroplasty of the PIP joint when either the: (1) patient is in need of a revision of failed PIP prosthesis(es); or (2) patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumaic arthritic PIP joint. |
| H970005 30-Apr-1998 98M-0452 | Perma-Flow® Coronary Graft, Model 2C10 | Possis Medical, Inc. Minneapolis, MN 55433 | For single or multiple vessel coronary artery bypass in patients who are receiving coronary bypass grafting but who have inadequate autologous conduit to complete the required revascularization. |
| H970004 06-Apr-1998 98M-0435 | Excorim® Immunoadsorption System | Cobe BCT., Inc. Lakewood, CO 80215 | For use in the treatment of patients with hemophhilia A and B who have Factor VIII or Factor IX inhibitor titers above 10 Bethesda Units/ml (BU/ml). The purpose of the system is to lower the inhibitor levels so that routine clotting factor rerplacement therapy can be considered. It may be used in an acute setting (to control bleeding during an acute hemmorrhage or for emergency surgery) or as a preventive measure to prepare patients for elective surgery. |
| H970003 16-Dec-1997 98M-0163 | Urostim | William E. Kaplan, M.D. and Ingrid Richards, R.N., MSN Chicago, IL 60614 | For use in children for the treatment of neurogenic bladder disease secondary to spina bifida |
| H970001 30-Sep-1997 98M-0164 | King's College Hospital (KCH) Fetal Bladder Drainage Catheter | Rocket Medical PLC England | For urinary tract decompression following the diagnosis of post-vesicular obstructive uropathy in fetuses 18 to 32 weeks gestational age |
| H960001 14-Feb-1997 97M-0124 | Harrison Fetal Bladder Stent Set (Lowery Modification) | Cook OB/GYN® Spencer, IN 47460 | For fetal urinary tract decompression following the diagnosis of fetal post-vesicular obstructive uropathy in fetuses of 18 to 32 weeks gestational age |
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