XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL
FDA premarket approval P110019/S068 · decided 2014-07-03
Approval details
- PMA number
- P110019
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2014-04-21
- Decision date
- 2014-07-03
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL TO CHANGE THE OUTER LAYER THICKNESS SPECIFICATION FOR THE INNER MEMBER CATHETER COMPONENT FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT OVER THE WIRE (OTW) SYSTEM.
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