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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 AND H&L-B ONE-SHOT INTRODUCTION SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft and delivery system
ApplicantCOOK, INC.
PMA NumberP020018
Supplement NumberS003
Date Received12/22/2003
Decision Date04/15/2004
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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.
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