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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameZENITH FLEX AAA ENDOVASCULAR GRAFT & ZENITH RENU AAA ANCILLARY GRAFT WITH Z-TRAK INTRODUCTION SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK INCORPORATED
PMA NumberP020018
Supplement NumberS036
Date Received06/18/2010
Decision Date07/15/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a quality control test to the captor hemostatic valve tubing subassembly process.
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