|
Device | MEDTRONIC VASCULAR ENDURANT 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 | S059 |
Date Received | 12/20/2016 |
Decision Date | 01/17/2017 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of a change in laser equipment at Medtronic's approved supplier for the suprarenal stents on the Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac Stent Graft System and Endurant IIs Stent Graft System. |