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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.
 
DeviceGORE EXCLUDER BIFURCATED ENDOPROSTHESIS
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW.L. GORE & ASSOCIATES,INC
32360 N. North Valley Parkway
Phoenix, AZ 85085
PMA NumberP020004
Supplement NumberS004
Date Received05/27/2003
Decision Date10/15/2003
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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