ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING STENT SYSTEM
FDA premarket approval P060033/S031 · decided 2009-07-13
Approval details
- PMA number
- P060033
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic, Inc.
- Date received
- 2009-01-29
- Decision date
- 2009-07-13
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR CHANGES TO THE PATIENT GUIDE.
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