XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P070015/S054 · decided 2011-05-24
Approval details
- PMA number
- P070015
- Supplement
- S054
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2010-11-26
- Decision date
- 2011-05-24
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 2.25 MM XIENCE V EVEROLIMUS ELUTING CORONARY STEM SYSTEM. THIS DEVICE SIZE WILL BE MARKETED UNDER THE TRADE NAME XIENCE NANO EVEROLIMUS ELUTING CORONARY STEM SYSTEM AND WILL ALSO BE DISTRIBUTED AS THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THE ADDITION OF THE 2.25 MM XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM WILL EXPAND THE ORIGINALLY APPROVED INDICATIONS TO INCLUDE TREATMENT OF CORONARY ARTERY LESIONS WITH REFERENCE VESSE
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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 |