FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Coronary
PMA: P970020
·
Supplement: S017
·
Decision Dec 22, 1999
Classifications
1
FEI Numbers
28
Registration Numbers
28
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- ACS MULTI-LINK RX/OTW TRISTAR CORONARY STENT SYSTEM
- PMA Number
- P970020
- Supplement Number
- S017
- 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
- December 22, 1999
- Date Received
- June 21, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the ACS Multi-Link RX and OTW Tristar(TM) Coronary Stent Systems.
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 |