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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFLUENCY PLUS ENDOVASCULAR STENT GRAFT
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantBard Peripheral Vascular, Inc.
1415 W. 3rd St.
Tempe, AZ 85281
PMA NumberP130029
Date Received12/17/2013
Decision Date06/17/2014
Product Code PFV 
Docket Number 14M-0875
Notice Date 07/15/2014
Advisory Committee Cardiovascular
Clinical TrialsNCT01257438
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 
S013 
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