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Device | AFX ENDOVASCULAR AAA SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 2 Musick Irvine, CA 92618 |
PMA Number | P040002 |
Supplement Number | S035 |
Date Received | 11/01/2011 |
Decision Date | 12/06/2011 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MODIFIED CONTRALATERAL LIMB SUREPASS GUIDEWIRE HOLDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX AAA ENDOVASCULAR SYSTEM AND IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA. |
Post-Approval Study | Show Report Schedule and Study Progress |