XIENCE XPEDITION,XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
FDA premarket approval P110019/S058 · decided 2014-01-07
Approval details
- PMA number
- P110019
- Supplement
- S058
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- XIENCE XPEDITION,XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2013-12-09
- Decision date
- 2014-01-07
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN NORTH BRUNSWICK, NEW JERSEY.
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