|
Device | AFX2 Endovascular AAA System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 2 Musick Irvine, CA 92618 |
PMA Number | P040002 |
Supplement Number | S071 |
Date Received | 01/09/2023 |
Decision Date | 05/08/2023 |
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 of the protocol for the VQI and VISION EVAR Registry Analysis post-approval study (PAS) protocol. |