Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- MULTI-LINK RX TETRA/OTW TETRA CORONARY STENT SYSTEM
- PMA Number
- P970020
- Supplement Number
- S039
- 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
- May 23, 2002
- Date Received
- November 27, 2001
- Supplement Type
- Normal 180 Day Track
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR INCLUSION OF SIX-MONTH TRIAL DATA IN THE INSTRUCTIONS FOR USE BOOKLET FOR THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS. THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH REFERENCE VESSEL DIAMETERS OF 3.0 MM TO 4.0 MM; 2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <= 35 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 TO 4.0 MM; AND 3) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 2.5 MM TO 4.0 MM. LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. NOTE: THE 2.5 MM AND 2.75 MM DIAMETER STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE. THE 33 MM AND 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE AND PATIENTS WITH LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS.
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 |