|
Device | PROMUS ELEMENT PLUS/PROMUS PREMIER 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 | S107 |
Date Received | 05/14/2015 |
Decision Date | 06/11/2015 |
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 CHANGE EQUIPMENT TO OPTIMIZE INSPECTION OF THE PROXIMAL SUB-ASSEMBY FROM POINT-AND-CLICK SYSTEM TO DIGITAL VISION TECHNOLOGY. |