ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P060033/S014 · decided 2009-02-17
Approval details
- PMA number
- P060033
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic, Inc.
- Date received
- 2008-10-09
- Decision date
- 2009-02-17
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR AN EXTENSION OF THE IN-PROCESS SHELF-LIFE OF THE STENT COATING FORMULATIONS.
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