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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 VIABAHN ENDOPROSTHESIS
Classification Namestent, superficial femoral artery
Generic Nameperipheral endovascular stent graft
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040037
Supplement NumberS002
Date Received08/14/2006
Decision Date02/08/2007
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the endoprosthesis and delivery catheter design to reduce the overall delivery profile of the device by one french size.
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