ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P060033 · decided 2008-02-01
Approval details
- PMA number
- P060033
- Trade name
- ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic, Inc.
- Date received
- 2006-11-20
- Decision date
- 2008-02-01
- Days to decision
- 438 days
- Decision code
- APWD
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT ON THE OVER-THE-WIRE (OTW), RAPID EXCHANGE (RX), OR MULTI-EXCHANGE II (MX2) STENT DELIVERY SYSTEMS. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH <= 27 MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSELL DIAMETERS OF >= 25 MM TO <= 3.5 MM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| 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 |