XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110019/S066 · decided 2014-10-03
Approval details
- PMA number
- P110019
- Supplement
- S066
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2014-03-21
- Decision date
- 2014-10-03
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF 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 TO INCLUDE DE NOVO TOTAL CORONARY OCCLUSIONS.. THESE DEVICES ARE INDICATED FOR THE FOLLOWING:XIENCE V AND XIENCE NANO EVEROLIMUS ELUTIN
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