ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P060033/S081 · decided 2013-10-24
Approval details
- PMA number
- P060033
- Supplement
- S081
- Supplement type
- 30-Day Notice
- 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
- 2013-09-26
- Decision date
- 2013-10-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- ADDITION OF OPTICAL SENSORS TO THE GLASS SCALE OF THE FLOW METER AT THE SPECIFICATION LIMITS TO ASSIST THE OPERATOR IN ACCEPTING/ REJECTING THE HYPOTUBE UNDER INSPECTION.
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |