ACS MULTI-LINK RX DUET CORONARY STENT SYSTEM AND THE ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEM
FDA premarket approval P970020/S007 · decided 1999-01-12
Approval details
- PMA number
- P970020
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACS MULTI-LINK RX DUET CORONARY STENT SYSTEM AND THE ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-12-08
- Decision date
- 1999-01-12
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for an alternate sterilization site located at Advanced Cardiovascular Systems, 26531 Ynez Road, Temecular, CA 92591-4628.
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