S670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM
FDA premarket approval P000022/S003 · decided 2000-12-19
Approval details
- PMA number
- P000022
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- S670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic Vascular
- Date received
- 2000-11-24
- Decision date
- 2000-12-19
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- MANUFACTURING BONDING PROCESS CHANGE FOR CONVERSION BONDS AND JACKET BONDS.
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