|
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 | S058 |
Date Received | 10/06/2016 |
Decision Date | 02/23/2017 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00705718
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to transfer device component of the Talent Occluder to Endurant Stent Graft System. |