|
Device | Resolute Onyx Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC VASCULAR 3576 UNOCAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P160043 |
Supplement Number | S011 |
Date Received | 12/18/2017 |
Decision Date | 03/15/2018 |
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 to introduce changes to the annual stability study design for the Resolute Onyx Coronary Stent System and Resolute Integrity Coronary Stent System. |