Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN
- PMA Number
- P900043
- Supplement Number
- S042
- Device Class
- FDA Class 3
- Product Code
- MAF
- Generic Name
- STENT, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 4, 2004
- Date Received
- October 21, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A NEW SAPHENOUS VEIN GRAFT (SVG) INDICATION FOR THE BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS). THE DEVICE IS INDICATED FOR THE TREATMENT OF: PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<= 30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM;ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM; AND,PATIENTS WITH DE NOVO OR RESTENOTIC SAPHENOUS VEIN GRAFT LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAF | Stent, Coronary | FDA class 3 | Unknown |