|
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 | S031 |
Date Received | 02/25/2020 |
Decision Date | 04/09/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for introducing changes to the material of the desiccant (molecular sieve material) added to the product packaging post sterilization of the Resolute Onyx product. |