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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCOOK, INC.
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP020018
Supplement NumberS009
Date Received05/01/2006
Decision Date06/01/2006
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT ANCILLARY COMPONENT LABELING TO CLARIFY THE LENGTH LIMITATIONS FOR USE OF THE 58 MM LENGTH MAIN BODY EXTENSION WHEN USED IN CONJUNCTION WITH THE SHORTEST ZENITH MAIN BODY COMPONENTS.
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