|
Device | PROMUS ELEMENT PLUS EVEROLIMUS-ELEUTING 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 | S035 |
Date Received | 11/05/2012 |
Decision Date | 03/25/2013 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MODIFYING THE PRECAUTIONS REGARDING LONGITUDINAL STENT DEFORMATION IN THE DIRECTIONS FOR USE. |