|
Device | Promus Element Plus 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 | S164 |
Date Received | 03/08/2019 |
Decision Date | 01/03/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01589978
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for revisions to the labeling that incorporate the results of the PROMUS Element Plus Post-Approval Study. |