|
Device | Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC VASCULAR 3576 UNOCAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P160043 |
Supplement Number | S062 |
Date Received | 10/31/2022 |
Decision Date | 11/01/2022 |
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 Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product. |