XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110019/S001 · decided 2012-05-07
Approval details
- PMA number
- P110019
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2011-11-02
- Decision date
- 2012-05-07
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS, UK, LIMITED IN DERBYSHIRE, UNITED KINGDOM.
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