Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM
- PMA Number
- P900043
- Supplement Number
- S028
- 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
- September 21, 2001
- Date Received
- April 6, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A NEW INDICATION (ELECTIVE STENTING OF DE NOVO AND RESTENOTIC CORONARY ARTERIES) AND ADDITIONAL STENT DIAMETERS (4.5 AND 5.0 MM) FOR THE BX VELOCITY WITH HEPACOAT ON STENT SYSTEM. THE DEVICE, AS MODIFIED, IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) FOR 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; AND 2) FOR TREATMENT OF 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 IN 4.00 MM. THE 2.25 MM, 2.50 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
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 |