|
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 | S027 |
Date Received | 08/21/2019 |
Decision Date | 02/14/2020 |
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 revisions to the labeling that incorporate the results of the RESOLUTE ONYX Core (2.25 mm - 4.0 mm) and REOSLUTE ONYX 2.00 mm Clinical Studies. |