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Device | ZENITH AAA ENDOVASCULAR GRAFT WITH H&L ONE SHOT INTRODUCTION SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | COOK, INC. 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
PMA Number | P020018 |
Supplement Number | S022 |
Date Received | 11/13/2006 |
Decision Date | 09/25/2007 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE 304V STAINLESS STEEL WIRE SUPPLIER?S PROCESS TO INCLUDE 100% EDDY CURRENT TESTING. |