ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P060033/S088 · decided 2014-03-04
Approval details
- PMA number
- P060033
- Supplement
- S088
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic, Inc.
- Date received
- 2014-02-03
- Decision date
- 2014-03-04
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A RECONCILIATION PROCESS FOR COMPLIANCE CHART LABELS.
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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