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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameGORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Classification Namesystem, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP130006
Date Received04/01/2013
Decision Date12/05/2013
Product Code
PFV[ Registered Establishments with PFV ]
Docket Number 13M-1605
Notice Date 12/24/2013
Advisory Committee Cardiovascular
Clinical Trials NCT00737672
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the gore viabahn endoprosthesis and the gore viabahn endoprosthesis with heparin bioactive surface. This device is indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (av) access grafts.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 
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