|
Device | PROMUS PREMIER EVEROLIMUS-ELUTING PLANTINUM 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 | S118 |
Date Received | 01/20/2016 |
Decision Date | 04/19/2016 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a change in colorant used in the distal tip component of the delivery catheter. |