MULTI-LINK VISION CORONARY STENT SYSTEMS
FDA premarket approval P970020/S048 · decided 2007-02-16
Approval details
- PMA number
- P970020
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MULTI-LINK VISION CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2007-01-19
- Decision date
- 2007-02-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- MODIFICATION IN THE DOSE RANGE AND CONVEYOR SPEED FOR E-BEAM STERILIZATION FOR THE MULTI-LINK AND MULTI-LINK VISION CORONARY STENT SYSTEMS.
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