ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P060033/S069 · decided 2012-07-31
Approval details
- PMA number
- P060033
- Supplement
- S069
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic, Inc.
- Date received
- 2012-03-19
- Decision date
- 2012-07-31
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (WITH THE LATEST AVAILABLE FOLLOW-UP CLINICAL DATA FROM THE ENDEAVOR CLINICAL TRIAL PROGRAMS).
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