|
Device | Resolute Onyx Coronary Stent Systems |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC VASCULAR 3576 UNOCAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P160043 |
Supplement Number | S026 |
Date Received | 08/09/2019 |
Decision Date | 08/12/2019 |
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 Implementation of a new dishwasher and water purification system in the shared glassware cleaning area within the Medtronic Ireland manufacturing facility. |