XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XP
FDA premarket approval P110019/S045 · decided 2013-07-26
Approval details
- PMA number
- P110019
- Supplement
- S045
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XP
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2013-05-08
- Decision date
- 2013-07-26
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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510(k) clearances by this applicant
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