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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 NameGORE EXCLUDER BIFURCATED ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP020004
Supplement NumberS004
Date Received06/04/2003
Decision Date10/15/2003
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of larger size contralateral leg components for the excluder bifurcated endoprosthesis (ebe) and for the addition of the w. L. Gore & associates woody springs facility located in flagstaff, arizona, which will be used to manufacture the larger sized contralateral leg components.
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