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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 AAA ENDOPROSTHESIS
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. Gore & Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP020004
Supplement NumberS075
Date Received10/04/2012
Decision Date11/20/2012
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MODIFICATION OF THE DELIVERY SYSTEM FOR THE FOLLOWING DEVICE COMPONENTS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS ON THE SIM-PULL (ORIGINAL) AND C3 (EMDS) CATHETERS IN ORDER TO LOWER THEIR DELIVERY PROFILES AS OUTLINED BELOW: 1) 16, 18 AND 20 MM CONTRALATERAL LEGS FROM 18 FR TO 12 FR; 2) 23 MM CONTRALATERAL LEG FROM 18 FR TO 14 FR; 3) 27 MM COLATERAL LEG FROM 18 FR TO 15 FR; 4) 23, 26, 28.5 MM AORTIC EXTENDERS FROM 18 FR TO 16 FR; 5) 32 MM AORTIC EXTENDER FROM 20 FR TO 17 FR; 6) 31 MM TRUNK-IPSILATERAL LEG WITH SIM-PULL DELIVERY SYSTEM FROM 20 FR TO 18 FR AND 7) 31 MM TRUNK-IPSILATERAL LEG WITH C3 DELIVERY SYSTEM FROM 20 FR TO 18 FR.
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