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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 AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK MEDICAL INCORPORATED
PMA NumberP020018
Supplement NumberS011
Date Received09/18/2006
Decision Date07/01/2008
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval or the: 1) addition of an automated laser welding process; and 2) removal of the subsequent ultrasonic cleaning step from the soldering process.
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