|
Device | Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC VASCULAR 3576 UNOCAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P160043 |
Supplement Number | S025 |
Date Received | 04/22/2019 |
Decision Date | 10/22/2019 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for implementing the option of a reusable polypropylene sterilization tote for the transportation of the product to the contract sterilization supplier, during sterilization and return from the contract sterilization supplier. |