|
Device | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM 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 | S010 |
Date Received | 03/20/2012 |
Decision Date | 08/16/2012 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR HARDWARE AND SOFTWARE CHANGES TO THE CATHETER PORT MANUFACTURING PROCESS. |