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Device | Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC VASCULAR 3576 UNOCAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P160043 |
Supplement Number | S080 |
Date Received | 03/29/2024 |
Decision Date | 04/10/2024 |
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 internal facility transfer of component extrusion and secondary cutting manufacturing operations |