XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P070015/S036 · decided 2011-05-23
Approval details
- PMA number
- P070015
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2010-04-29
- Decision date
- 2011-05-23
- Days to decision
- 389 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR UPDATES TO YOUR LABELING TO INCLUDE 1-YEAR RESULTS FROM THE SPIRIT IV TRIAL, A POOLED SPIRIT II-III-IV ANALYSIS, GENDER-SPECIFIC ANALYSES, AND UPDATED RESULTS FROM THE SPIRIT FIRST, II, AND III TRIALS.
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| 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 |