XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
FDA premarket approval P110019/S002 · decided 2012-01-04
Approval details
- PMA number
- P110019
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2011-11-14
- Decision date
- 2012-01-04
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL TO UPDATE THE LABELING FOR THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO REFLECT AN 18 MONTH SHELF LIFE.
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