|
Device | PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P110010 |
Supplement Number | S137 |
Date Received | 12/05/2016 |
Decision Date | 03/23/2017 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a manufacturing site located at Boston Scientific Maple Grove, Two Scimed Place, Maple Grove, Minnesota for the Poly n-Butyl Methacrylate (PBMA) purification of the Promus PREMIER Stent system |