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Device | GORE EXCUDER AAA EDOPROSTHESIS |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W.L. GORE & ASSOCIATES,INC 32360 N. North Valley Parkway Phoenix, AZ 85085 |
PMA Number | P020004 |
Supplement Number | S083 |
Date Received | 06/12/2013 |
Decision Date | 07/11/2013 |
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 IMPLEMENTATION OF A NEW SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) TAPE USINGAN ALTERNATE PTFE RESIN RAW MATERIAL. |
Post-Approval Study | Show Report Schedule and Study Progress |