ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM
FDA premarket approval P970020/S002 · decided 1999-02-03
Approval details
- PMA number
- P970020
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-02-24
- Decision date
- 1999-02-03
- Days to decision
- 344 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for an alternate method of sterilization (Electron Beam) for the ACS RX Multi-Link(TM) HP and the ACS OTW Multi-Link(TM) HP Coronary Stent Systems.
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