XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM
FDA premarket approval P110019/S061 · decided 2014-03-26
Approval details
- PMA number
- P110019
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2014-01-13
- Decision date
- 2014-03-26
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR A LABELING CHANGE FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND THE XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM FOR THE OTW PLATFORM. THIS LABELING CHANGE REQUESTED A SHELF LIFE EXTENSION FROM 24 TO 36 MONTHS.
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