MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (CSS)
FDA premarket approval P020047/S014 · decided 2008-12-10
Approval details
- PMA number
- P020047
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (CSS)
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular
- Date received
- 2008-11-10
- Decision date
- 2008-12-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.
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