|
Device | PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent S |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P110010 |
Supplement Number | S158 |
Date Received | 06/13/2018 |
Decision Date | 07/11/2018 |
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 Parametric release of product sterilized in the BSC2000-2 cycle. |