|
Device | PROMUS Element PLUS/PREMIER/ELITE 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 | S176 |
Date Received | 03/12/2020 |
Decision Date | 05/19/2020 |
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 Corp. in Ballybrit Business Park Galway, Ireland for sterilization. |