|
Device | XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S018 |
Date Received | 05/29/2012 |
Decision Date | 10/05/2012 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order 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-PROCESS INSPECTION. THE COMPANY HAS PROVIDED THE ALTERNATIVE SOLUTION. |