VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 OTW
FDA premarket approval P020047/S034 · decided 2011-05-12
Approval details
- PMA number
- P020047
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 OTW
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular
- Date received
- 2011-04-13
- Decision date
- 2011-05-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- A MANUAL TO AN AUTOMATED PROCESS CHANGE FOR PACKAGING LABELING INSPECTION.
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