|
Device | Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S102 |
Date Received | 03/11/2022 |
Decision Date | 04/07/2022 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for implementation of changes to the taper tip manufacturing and inspection processes at the supplier and updates to the inspection plan for the taper tip assembly at Medtronics receiving inspection. |