MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX ML-8
FDA premarket approval P020047/S029 · decided 2011-06-16
Approval details
- PMA number
- P020047
- Supplement
- S029
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX ML-8
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular
- Date received
- 2011-02-11
- Decision date
- 2011-06-16
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL TO REMOVE A REDUNDANT RECEIVING INSPECTION TEST.
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