XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110019/S018 · decided 2012-10-05
Approval details
- PMA number
- P110019
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2012-05-29
- Decision date
- 2012-10-05
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL TO ALLOW THE CORRESPONDING DRUG CONTENT VALUES TO BE CENTERED AROUND 100% LABEL CLAIM AND PROVIDE INCREASED PROBABILITY THAT INDIVIDUAL UNITS WILL HAVE A DRUG CONTENT OF GREATER THAN 90% OF THE LABELED CLAIM TO MEET THE CONDITION OF APPROVAL THAT "WITHIN 12 MONTHS OF PMA APPROVAL, YOU SHOULD SUBMIT A PMA SUPPLEMENT REQUESTING APPROVAL TO TIGHTEN THE IN-PROCESS COATING WEIGHT GAIN SPECIFICATION OR IMPLEMENT PROCEDURES TO RE-COAT STENTS WITH LESS THAN 95% COATING WEIGHT GAIN UPON IN-PROCE
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