XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
FDA premarket approval P070015 · decided 2008-07-02
Approval details
- PMA number
- P070015
- Trade name
- XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2007-06-01
- Decision date
- 2008-07-02
- Days to decision
- 397 days
- Decision code
- APWD
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, WHICH WILL ALSO BE DISTRIBUTED AS THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
| PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067) | Abbott Vascular, Inc. | 2013-01-29 |
| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |