|
Device | PROMUS ELEMENT PLUS 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 | S059 |
Date Received | 08/20/2013 |
Decision Date | 09/17/2013 |
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 USE OF AN ALTERNATE MID-SHAFT BONDING PROCESS IN THE MANUFACTURE OF THE PROMUS ELEMENT PLUS STENT DELIVERY CATHETER. |