|
Device | Promus Element plus Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and over the wire/ Promus Premie |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P110010 |
Supplement Number | S146 |
Date Received | 08/24/2017 |
Decision Date | 09/22/2017 |
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 Change the hanger clamp used for the balloon manufacturing process. |