ACS MULTI-LINK RX DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS
FDA premarket approval P970020/S011 · decided 1999-05-06
Approval details
- PMA number
- P970020
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ACS MULTI-LINK RX DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1999-02-26
- Decision date
- 1999-05-06
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for a 5-year post-approval study protocol for the ACS MULTI-LINK RX and OTW DUET(TM) Coronary Stent Systems.
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