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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameFLUENCY PLUS ENDOVASCULAR STENT GRAFT
Classification Namesystem, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
ApplicantBARD PERIPHERAL VASCULAR, INC.
PMA NumberP130029
Date Received12/19/2013
Decision Date06/17/2014
Product Code
PFV[ Registered Establishments with PFV ]
Docket Number 14M-0875
Notice Date 07/15/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01257438
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the fluency plus endovascular stent graft. This device is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft.
Approval Order Approval Order
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