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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 AAA ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP020004
Supplement NumberS075
Date Received10/04/2012
Decision Date11/20/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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