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  1. HDE Approvals

Listing of CDRH Humanitarian Device Exemptions

Approval Date HDE Number
and Docket Number
Device Name Company Name and Address Device Description / Device Indications
02/17/2021 H200001 Patient Specific Talus Spacer Additive Orthopaedics, LLC.
Philadelphia, PA 19103
Approval of the Patient Specific Talus Spacer. This device is indicated for avascular necrosis of the ankle joint. The anatomical landmarks necessary for the design and creation of the Additive Orthopaedics Patient Specific Talus Spacer must be present and identifiable on computed tomography scan.
12/01/2020 H190001 Plasma Delipidation System (PDS-2TM System) HDL Therapeutics, Inc.
Philadelphia, PA
19103
Approval for the Plasma Delipidation System (PDS-2TM System). This device is indicated to reduce coronary artery atheroma in adult patients with homozygous familial hypercholesterolemia (HoFH) who are either inadequately responsive to or intolerant of maximal therapy for HoFH, including the latest medications and other device therapies approved by the FDA.
11/27/2020 H190003 Sonalleve MR- HIFU Profound Medical, Inc.
Mississauga, Ontario CANADA
Approval for the Sonalleve MR- HIFU.  This device is indicated for the treatment of osteoid osteomas in the extremities.
08/23/2019 H170001 Minimally Invasive Deformity Correction (MID-C) System ApiFix, Ltd. Approval for the Minimally Invasive Deformity Correction (MID-C) System. This device is indicated for use in patients with adolescent idiopathic scoliosis (AIS) for treatment of single curves classified as Lenke 1 (thoracic major curve) or Lenke 5 (thoracolumbar/lumbar major curve), having a Cobb angle of 45 to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs, and thoracic kyphosis less than 55 degrees as measured from T5 to T12.
08/16/2019 H190005 The Tether™ - Vertebral Body Tethering System Zimmer Biomet Spine, Inc. Approval for The Tether™ - Vertebral Body Tethering System. This device is indicated for skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear.
05/23/2019 H180002 NovoTTF™-100L System Novocure, Ltd.
Portsmouth, NH03801
Approval for the NovoTTF™-100L System. This device is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.
09/14/2018 H170004 PK Papyrus Covered Coronary Stent System Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the PK Papyrus Covered Coronary Stent System. This device is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.

03/20/2018
H170002
75-Day
LIPOSORBER® LA-15 System Kaneka Pharma America LLC.
Vienna, VA
22180
Approval for the LIPOSORBER® LA-15 System to expand the indication to include adult patients with nephrotic syndrome. The LIPOSORBER® LA-15 is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, are unsuccessful or not well tolerated and the patient has a GFR ≥ 60 ml/min/1.73m2 or the patient is post renal transplantation.
06/19/2017 H160002 PulseRider Aneurysm Neck Reconstruction Device Pulsar Vascular, Inc.
Los Gatos, CA 95032
Approval for the PulseRider Aneurysm Neck Reconstruction Device. This device is indicated for use with neurovascular embolic coils in patients ≥ 18 years of age for the treatment of unruptured wide-necked intracranial aneurysms with neck widths ≥ 4 mm or dome to neck ratio < 2 originating on or near a vessel bifurcation of the basilar tip or carotid terminus with at least a portion of the aneurysm neck overlapping the lumen of the parent artery. The inflow vessels should have diameters from 2.7 mm to 4.5 mm.
05/12/2017 H150003
75-Day
Flourish™ Pediatric Esophageal Atresia Device Wilson-Cook Medical Inc.
Winston-Salem, NC 27105
Approval for the Flourish™ Pediatric Esophageal Atresia Device. The Flourish™ Pediatric Esophageal Atresia Device is indicated for use in lengthening atretic esophageal ends and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. This device is indicated for atretic segments ≤ 4cm apart.
01/10/2017 H070005 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.
12/18/2015 H130006 FENIX™ Continence Restoration System Torax Medical, Inc.
Shoreview, MN
55126
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).
12/18/2015 H140005 PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome / Myeloproliferative Disease (MDS / MPD) ARUP Laboratories
Salt Lake City, UT
84108
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.
12/18/2015 H140006 KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) ARUP Laboratories
Salt Lake City, UT
84108
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.
07/16/2015 H080004
2015-M-2584
Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Device Integrum AB
Alexandria, Virginia
22314

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:

  • Recurrent skin infections and ulcerations in the socket contact area
  • Pain
  • A short stump preventing the use of socket prosthesis
  • Volume fluctuation in the stump
  • Soft tissue scarring
  • Extensive area of skin grafting
  • Socket retention problems due to excessive perspiration
  • Restricted mobility
03/05/2015 H130001 Kaneka Lixelle® β2-microglobulin Apheresis Column Kaneka Pharma America, LLC
New York, NY
10036
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).
01/23/2015 H140001 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.
12/12/2014 H130007 Barostim neo® Legacy System CVRx, Inc.
Minneapolis, MN
55445
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.
08/26/2014 H130004
2014-M-1280
Pleximmune™ Plexision Inc
Pittsburg, PA
15224

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:

  1. Pre-transplantation period: For blood samples collected before transplantation, the test predicts the risk of transplant rejection within 60 days after transplantation; and
  2. Early and late post-transplantation period: For blood samples collected within 60 days (early) after transplantation and for blood samples collected at 200 or more days (late) after transplantation, the test predicts the risk of transplant rejection within 60 days after sampling.
08/12/2014 H120003
2014-M-1265
XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate XVIVO Perfusion, Inc.
Englewood, CO
80110
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.
07/25/2014 H130005
2014-M-1114
Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.) MicroVention, Inc.
Tustin, CA
92780
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.
10/10/2013 H120005 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.
02/13/2013 H110002
FDA-2013-M-0205
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.
12/16/2011 H100004
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.
11/18/2011 H090002
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.
11/01/2011 H100008
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. NOTE: This HDE is superseded by PMA P120006
09/28/2011 H100006
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.
04/01/2011 H100002
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.
03/10/2011 H080005
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.
01/25/2010 H080002
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 surgery in the management of pediatric and adult patients with the following clinical conditions:
  • Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm
    in diameter when originally implanted and
  • Dysfunctional Right Ventricular Outflow Tract (RVOT) conduits with a clinical indication
    for intervention, and either:
    • Regurgitation: > moderate regurgitation, or
    • Stenosis: mean RVOT gradient > 35 mmHg.
NOTE: This HDE is superseded by PMA P140017.
02/19/2009 H050003
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).
10/24/2008 H060002
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.
10/10/2008 H040004
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.
10/07/2008 H070004
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.
06/17/2008 H070003
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.
10/25/2007 H990002
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. Jurisdiction for this product has been transferred to CBER.
05/08/2007
07M-0190
H060001
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.
04/11/2007 H060003
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.
01/24/2007 H060004
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.
09/05/2006 H040006
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
  • are less than 75 years old,
  • require multiple inotropic support,
  • are not treatable by LVAD destination therapy, and
  • are not weanable from biventricular support if on such support.
03/31/2006 H040005
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.
08/03/2005 H050001
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.
03/30/2005 H030005
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.
08/24/2004 H030009
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
    Rib fusion and scoliosis
    Hypoplastic thorax syndrome, including
    • Jeune's syndrome
    • Achondroplasia
    • Jarcho-Levin syndrome
    • Ellis van Creveld syndrome
NOTE: This HDE is superseded by 510(k) K142587.
07/26/2004 H040002
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:

  • who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles;
  • who are 21 years of age or older;
  • who have clear central corneas;
  • who have a corneal thickness of 450 microns or greater at the proposed incision site; and
  • who have corneal transplantation as the only remaining option to improve their functional vision.
04/07/2004 H020008
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.
02/25/2004 H030003
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>2) who are in NYHA Class IV end stage heart failure, are refractory to medical therapy and who are (listed) candidates for cardiac transplantation.
2/24/2004 H030004
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.
11/21/2003 H020003
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:
  • Pulmonary Stenosis
  • Tetralogy of Fallot
  • Truncus Arteriosus
  • Transposition with Ventricular Septal Defect (VSD)
  • Pulmonary Atresia
In addition, the conduit is indicated for the replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits.
07/07/2003 H020004
03M-0305
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.
04/15/2003 H020007
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
09/02/2002 H020002
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 <>
08/09/2002 H010004
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
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.
03/22/2002 H010005
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.
12/19/2001 H000002
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:
  • who exhibit symptomatology supportive of visual defect: reduced best spectacle-corrected visual acuity, debilitating glare, monocular diplopia (double vision), and/or debilitating halos; and,
  • who pre-operatively have at least a 6 µm difference on the elevation topography, from the lowest point to the highest point, over a 6.5 mm diameter or over the patient's pupil diameter as measured by the Zeiss Humphrey topographer, whichever is larger
10/17/2001 H010002
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.
08/28/2001 H010001
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:
  1. patient is in need of a revision of failed MCP 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 traumatic MCP joint.
03/19/2001 H000004
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).
02/21/2001 H990013
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). Jurisdiction for this product has been transferred to CBER.
01/10/2001 H000001
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.
05/11/2000 H990012
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).
03/31/2000 H990014
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.
03/09/2000 H990008
00M-1228
Telescopic Plate Spacer (TPS) Spinal System Interpore Cross International The sponsor has withdrawn this HDE effective Sept. 1, 2010
02/01/2000 H990011
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.
12/10/1999 H980006
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.
12/07/1999 H990007
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.
09/30/1999 H980007
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.
09/28/1999 H990005
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.
09/20/1999 H990003
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.
09/08/1999 H990004
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.
02/19/1999 H980008
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
12/28/1998 H980005
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.
09/28/1998 H980002
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.
04/30/1998 H970005
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.
04/06/1998 H970004
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.
12/16/1997 H970003
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
09/30/1997 H970001
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
02/14/1997 H960001
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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