|
Device | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE) |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P110010 |
Supplement Number | S021 |
Date Received | 06/26/2012 |
Decision Date | 08/23/2012 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |