|
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 | S191 |
Date Received | 03/25/2021 |
Decision Date | 04/22/2021 |
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 Alternative process to allow for the automation of top assembly process steps for the manufacture of stent delivery catheters. |