Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM
- PMA Number
- P970020
- Supplement Number
- S035
- 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
- January 14, 2002
- Date Received
- August 6, 2001
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF AN INDICATION TO USE THE 4.5 MM AND 5.0 MM ULTRA OTW AND RX FOR THE TREATMENT OF SAPHENOUS VEIN GRAFT (SVG) LESIONS. THE MULTI-LINK RX ULTRA AND MULTI-LINK OTW ULTRA CORONARY STENT SYSTEM WILL INCLUDE THE FOLLOWING INDICATION: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL EIAMETERS RANGING FROM 3.5 MM TO 5.0 MM; 2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <=35) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.5 MM TO 5.0 MM; AND 3) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=35 MM IN LENGTH WITH REFERENCE DIAMETERS IN THE RANGE OF 3.5 MM TO 5.0 MM. LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. NOTE: THE 38 MM LENTGH 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 |