ACS MULTI-LINK RX/OTW TRISTAR CORONARY STENT SYSTEM
FDA premarket approval P970020/S017 · decided 1999-12-22
Approval details
- PMA number
- P970020
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS MULTI-LINK RX/OTW TRISTAR CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1999-06-21
- Decision date
- 1999-12-22
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for the ACS Multi-Link RX and OTW Tristar(TM) Coronary Stent Systems.
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