|
Device | Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC VASCULAR 3576 UNOCAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P160043 |
Supplement Number | S078 |
Date Received | 02/12/2024 |
Decision Date | 03/08/2024 |
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 use of additional sterilization chambers at the established sterilization site with a previously qualified and approved sterilization cycle |