|
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 | S051 |
Date Received | 06/12/2014 |
Decision Date | 07/11/2014 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement ALTERNATE POLYTETRAFLUOROETHYLENE (PTFE) RESIN. |
Post-Approval Study | Show Report Schedule and Study Progress |