|
Device | Endurant Stent Graft Family |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S092 |
Date Received | 04/28/2021 |
Decision Date | 05/28/2021 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to provide supplemental data from the ANCHOR Registry from an additional 60 subjects treated for short neck infrarenal aneurysms to provide support long-term safety and effectiveness data on the short neck indication |