XIENCE PRIME AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110019/S009 · decided 2012-09-14
Approval details
- PMA number
- P110019
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- XIENCE PRIME AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2012-01-24
- Decision date
- 2012-09-14
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL TO UPDATE THE PRODUCT LABELING CONTAINED IN THE INSTRUCTIONS FOR USE (IFU) AND PATIENT GUIDE FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE UPDATES SPECIFICALLY INCLUDED LONGER TERM FOLLOW-UP DATA TO ALLAPPLICABLE CLINICAL TRIALS FOR THE DEVICES.
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