FDA PMA
Approved
🇺🇸 United States
PMA: P970020
·
Supplement: S001
·
Decision Aug 4, 1998
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- ACS MULTI-LINK TM CORONARY STENT SYSTEM WITH THE 25MM STENT LENGTH
- PMA Number
- P970020
- Supplement Number
- S001
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 4, 1998
- Date Received
- February 3, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for ACS RX Multi-Link HP(TM) Coronary Stent System with the 25 mm stent length.