XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
FDA premarket approval P110019/S070 · decided 2014-09-03
Approval details
- PMA number
- P110019
- Supplement
- S070
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2014-06-04
- Decision date
- 2014-09-03
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL TO CHANGE THE DISTAL BALLOON SHAFT, DISTAL OUTER MEMBER AND PROXIMAL HYPOTUBE COMPONENTS FOR THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM. YOU INDICATED THAT UPON IMPLEMENTATION OF THESE CHANGES, THE NEW NAME FOR THE CORONARY STENT SYSTEM WILL BE THE XIENCE ALPINE¿ EVEROLIMUS ELUTING CORONARY STENT SYSTEM.
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