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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.
Classification Namesystem, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Generic Nameendoprosthesis
ApplicantC.R. BARD, INC.
PMA NumberP060002
Supplement NumberS034
Date Received02/14/2014
Decision Date08/13/2014
Product Code
PFV[ Registered Establishments with PFV ]
Advisory Committee Cardiovascular
Clinical Trials NCT00677235
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updated instructions for use (ifu) to include data from the postapproval study (renova).