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Device | ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B 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 | S003 |
Date Received | 12/22/2003 |
Decision Date | 04/15/2004 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO INCREASE THE STENT SPACING (FROM 0-3 MM TO 5 += 1MM) ON THE MAIN BODY AND THE MAIN BODY EXTENSION COMPONENTS OF THE ZENITH AAA ENDOVASCULAR GRAFT. |