XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110019/S078 · decided 2015-10-22
Approval details
- PMA number
- P110019
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2015-09-24
- Decision date
- 2015-10-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- CHANGE TO THE ACCEPTANCE SAMPLING SYSTEM FOR DISLODGEMENT TESTING FOR THE XIENCE PRIME AND XIENCE PRIME II EVEROLIMUS ELUTING CORONARY STENT SYSTEM.
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