|
Device | Resolute Onyx Zotarolimus-Eluting Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC VASCULAR 3576 UNOCAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P160043 |
Supplement Number | S060 |
Date Received | 04/07/2022 |
Decision Date | 09/29/2022 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for updated labeling for the the Resolute Onyx Zotarolimus-Eluting Coronary Stent System electronic Instructions for Use (eIFU) to reflect the long-term data from The RESOLUTE ONYX CTO Post-Approval Study. |