|
Device | Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P110010 |
Supplement Number | S185 |
Date Received | 11/19/2020 |
Decision Date | 12/16/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement approval for the addition of a new ISO class 8 Cleanroom to support expansion of the Stent Delivery Catheter production unit |