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Approval Date and Docket Number
|Device Name||Company Name and Address||Device Description /
|H070005 1/10/17||AMPLATZER™ Post-Infarct Muscular VSD Occluder||AGA Medical Corporation
5050 Nathan Lane North Plymouth, MN 55442
|Approval for the AMPLATZER Post-Infarct Muscular VSD Occluder. The AMPLATZER Post-Infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post myocardial infarct muscular ventricular septal defects in patients who are not satisfactory surgical candidates.|
|FENIX™ Continence Restoration System||Torax Medical, Inc.
|Approval for the FENIX™ Continence Restoration System. This device is indicated for the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation).|
|PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome / Myeloproliferative Disease (MDS / MPD)||ARUP Laboratories
Salt Lake City, UT
|Approval for the PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD). This device is indicated for the qualitative detection of PDGFRB gene rearrangement from fresh bone marrow samples of patients with MDS/MPD with a high index of suspicion based on karyotyping showing a 5q31~33 anomaly. The PDGFRB FISH assay is indicated as an aid in the selection of MDS/MPD patients for whom Gleevec (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.|
|KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM)||ARUP Laboratories
Salt Lake City, UT
|Approval for the KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM). KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) (referred to as the "KIT D816V assay") is an in vitro diagnostic test intended for qualitative polymerase chain reaction (PCR) detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis. The KIT D816V mutational assay is indicated as an aid in the selection of ASM patients for whom Gleevec® (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.|
|Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Device||Integrum AB
Approval for the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Device. The OPRA device is indicated for patients who have transfemoral amputation due to trauma or cancer and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA device is intended for skeletally mature patients.
The patient failed to receive benefit from a socket prostheses due to problems such as:
|Kaneka Lixelle® β2-microglobulin Apheresis Column||Kaneka Pharma America, LLC
New York, NY
|Approval for the Lixelle® β2-microglobulin Apheresis Column (also called the Beta2-Microglobulin Apheresis Column or β2M). This device is indicated for the treatment of patients with clinically diagnosed dialysis-related amyloidosis (DRA).|
|Impella RP System||ABIOMED, Inc.
Danvers, MA 01923
|Approval for the Impella RP System. This device is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area >=1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.|
|Barostim neo® Legacy System||CVRx, Inc.
|Approval for the Barostim neo® Legacy System. This device is indicated for use in patients with resistant hypertension who have had bilateral implantation of the Rheos® Carotid Sinus Leads Models 1010R, 1010L, 1014L, and 1014R (which have been discontinued and are obsolete) and were determined responders in the Rheos® pivotal clinical study.|
Approval for Pleximmune™. This device is indicated for: The Pleximmune™ test is intended to be performed at a single laboratory to measure the CD154 expression on T-cytotoxic Memory cells (TcM) in patient's peripheral blood lymphocytes (PBL) isolated from heparinized whole blood (anticoagulant – sodium heparin). The Pleximmune™ test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The Pleximmune™ test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.
The Pleximmune™ test is intended for use at the following time periods:
|XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate||XVIVO Perfusion, Inc.
|Approval for the XPS™ System with STEEN Solution™ Perfusate. The device is indicated for the flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation.|
|Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.)||MicroVention, Inc.
|Approval for the Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.). The device is indicated for use with bare platinum embolic coils for the treatment of unruptured, wide-neck (neck ≥ 4 mm or dome to neck ratio < 2 mm), intracranial, saccular aneurysms arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 4.5 mm.|
|Kaneka Liposorber® LA-15 System||Kaneka Pharma America LLC||Approval for the Kaneka Liposorber® LA-15 System. The device is indicated for use in the treatment of pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when: 1) Standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, are unsuccessful or not well tolerated and the patient has a GFR ≥ ml/min/1.73m2; or 2) The patient is post renal transplantation.|
|Argus® II Retinal Prosthesis System||Second Sight Medical Products, Inc.||This epiretinal prosthesis is surgically implanted in and on the eye and includes an antenna, an electronics case, and an electrode array. The Argus® II Retinal Prosthesis System is intended for patients aged 25 years and older with bare or no light perception vision caused by advanced retinitis pigmentosa.|
|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.|
|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.|
|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. NOTE: This HDE is superseded by PMA P120006|
|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.|
|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.|
|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.|
|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
NOTE: This HDE is superseded by PMA P140017.
|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).|
|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.|
|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.|
|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.|
|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.|
|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. Jurisdiction for this product has been transferred to CBER.|
|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.|
|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|
|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.|
|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
|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.|
|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.|
|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.|
|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
NOTE: This HDE is superseded by 510(k) K142587.
|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:
|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.|
|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.|
|Heartsbreath||Menssana Research Inc.
1 Horizon Road
Fort Lee, NJ 07024-6510
|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.|
|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:
|Dermagraft||Smith and Nephew Wound Management||This device has been withdrawn by the sponsor as of September 28, 2007. Jurisdiction for this product has been transferred to CBER.|
|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|
|Neuroform Microdelivery Stent System||SMART Therapeutics, Inc.
2551 Merced St.
San Leandro, CA 94577
|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.|
|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|
|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.|
|Ascension® PIP||Ascension Orthopedics, Inc.
|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.|
|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:
|OP-1™ Implant||Stryker Biotech
|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.|
|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:
|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).|
|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). Jurisdiction for this product has been transferred to CBER.|
|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.|
|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).|
|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.|
|Telescopic Plate Spacer (TPS) Spinal System||Interpore Cross International||
The sponsor has withdrawn this HDE effective Sept. 1, 2010
|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.|
|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.|
|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.|
|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.|
|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.|
|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.|
|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.|
|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|
|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.|
|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.|
|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.|
|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.|
|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|
|King's College Hospital (KCH) Fetal Bladder Drainage Catheter||Rocket Medical PLC
|For urinary tract decompression following the diagnosis of post-vesicular obstructive uropathy in fetuses 18 to 32 weeks gestational age|
|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|