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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.
 
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
Supplement NumberS003
Date Received06/15/2015
Decision Date07/15/2015
Product Code PFV 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO IMPLEMENT AN ADDITIONAL QUALITY CONTROL INSPECTION STEP.
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