|
Device | Resolute Onyx Zotarolimus-Eluting Coronary Stent System (hereafter called Resolute Onyx) |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC VASCULAR 3576 UNOCAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P160043 |
Supplement Number | S046 |
Date Received | 04/12/2021 |
Decision Date | 05/11/2021 |
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 Transfer of component extrusion manufacturing operations from the Santa Rosa to the Danvers site. |