XIENCE PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110019/S075 · decided 2015-09-23
Approval details
- PMA number
- P110019
- Supplement
- S075
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- XIENCE PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2015-02-02
- Decision date
- 2015-09-23
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE DEVICES ARE INDICATED FOR THE FOLLOWING:XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V S
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