Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S070 |
Date Received | 03/15/2022 |
Decision Date | 12/06/2022 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the updates to the AFX2 Endovascular AAA System labeling (i.e., Instructions For Use (IFU), patient guide, and implant card). |
Post-Approval Study | Show Report Schedule and Study Progress |
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