XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110019/S053 · decided 2014-02-28
Approval details
- PMA number
- P110019
- Supplement
- S053
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2013-08-30
- Decision date
- 2014-02-28
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR AN UPDATE TO THE LABELING TO REFLECT THE THREE YEAR POST APPROVAL STUDY FINDINGS FROM THE SPIRIT PRIME CLINICAL TRIAL.
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