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U.S. Department of Health and Human Services

Medical Devices

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Listing of CDRH Humanitarian Device Exemptions

HDE Number
Approval Date and Docket Number
Device NameCompany Name and AddressDevice Description /
Device Indications
H120005
10/10/2013
Kaneka Liposorber® LA-15 SystemKaneka Pharma America LLCApproval 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.
H110002
2/13/2013
FDA-2013-M-0205
Argus® II Retinal Prosthesis SystemSecond 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.
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 SystemBSD Medical CorporationThis 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 SystemTriVascular, 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 NOTE: This HDE is superseded by PMA P120006
H100006
09/28/2011
2011-M-0707
NeuRx DPS™, Diaphragm Pacing SystemSynapse 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 SystemNeuroVasx, 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 KitHUDElana, 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
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.
H050003
19-Feb-2009
09M-0090
Reclaim™ Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD) TherapyMedtronic NeuromodulationThis 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 SystemSpiration, 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 DeviceMedtronic 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, LLCThis 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/4Synapse 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 BiosurgeryThe 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.
H060001
08-May-2007
07M-0190
ENTERPRISE Vascular Reconstruction Device and Delivery SystemCordis 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 NeurovascularTreatment 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™ AssayFujirebio 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 HeartAbiomed, 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.
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 scopeKarl 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 CatheterBoston Scientific SmartThis 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 CatheterCoAxia, 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
Rib fusion and scoliosis
Hypoplastic thorax syndrome, including

  • Jeune's syndrome
  • Achondroplasia
  • Jarcho-Levin syndrome
  • Ellis van Creveld syndrome
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:

  • 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.
H020008
07-Apr-2004
04M-0165
OP-1 PuttyStryker 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 SystemMicroMed 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
HeartsbreathMenssana 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 ConduitMedtronic, IncThe 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.
H020004
07-Jul-2003
03M-0305
DermagraftSmith and Nephew Wound ManagementThis device has been withdrawn by the sponsor as of September 28, 2007. Jurisdiction for this product has been transferred to CBER.
H020007
15-Apr-2003
03M-0157
Medtronic Activa Dystonia TherapyMedtronic NeurologicalFor 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 SystemSMART 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 CatheterGuidant 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 OccluderAGA 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® PIPAscension 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:
  • 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
H010002
17-Oct-2001
01M-0482
OP-1™ ImplantStryker 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 ProsthesisAvanta 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.
H000004
19-Mar-2001
01M-0485
PROSTALAC Hip Temporary ProsthesisDePuy Orthopaedics, Inc., a Johnson & Johnson CompanyThis 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). Jurisdiction for this product has been transferred to CBER.
H000001
10-Jan-2001
010M-006
JOMED JOSTENT® Coronary Stent GraftJOMED ABFor 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 TestCardiovascular 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) SystemMedtronic, 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 SystemInterpore Cross International

The sponsor has withdrawn this HDE effective Sept. 1, 2010

H990011
01-Feb-2000
00M-0599
CardioSEAL® Septal Occlusion SystemNitinol Medical Technologies, IncThis 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 AdhesiveCryoLife, 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®" TreatmentShelhigh, 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 SystemNitinol Medical Technologies, IncFor 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™NeosphincterAmerican 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 SystemNitinol 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 SystemNeuroControl 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 SystemNeuroControl 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 ProsthesisAvanta Orthopaedics, IncFor 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 2C10Possis 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 SystemCobe 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
UrostimWilliam 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 CatheterRocket 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