VISION AND MINI-VISION CORONARY STENT SYSTEM
FDA premarket approval P020047/S049 · decided 2012-08-14
Approval details
- PMA number
- P020047
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISION AND MINI-VISION CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular
- Date received
- 2012-07-20
- Decision date
- 2012-08-14
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- ADDITION OF A NEW TEST TO INSPECT TUBING USED IN THE MANUFACTURING OF STENTS FOR THE DEVICES.
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