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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 VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantW.L. GORE & ASSOCIATES,INC
3250 W.KILTIE LANE
FLAGSTAFF, AZ 86001
PMA NumberP130006
Supplement NumberS043
Date Received09/11/2017
Decision Date10/10/2017
Product Code PFV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Use of additional machines for the manufacturing of the delivery systems for the GORE VIATORR TIPS Endoprosthesis with and without Controlled Expansion and the GORE VIABAHN Endoprosthesis with and without Heparin Bioactive Surface.
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