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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.
 
DeviceFLAIR ENDOVASCULAR STENT GRAFT
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantBard Peripheral Vascular
1625 W Third St.
Tempe, AZ 85281
PMA NumberP060002
Supplement NumberS027
Date Received07/19/2012
Decision Date01/16/2013
Withdrawal Date09/12/2022
Product Code PFV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LINE EXTENSION OF THE FLAIR® ENDOVASCULAR STENT GRAFT TO ADD A 70 MM LENGTH. IN ADDITION, THERE ARE THREE ADDITIONAL MINOR CHANGES. THESE INCLUDED: MANUFACTURING CORE MODIFICATION, DELIVERY SYSTEM FLARING MANDREL MODIFICATION, AND CHAMFER OF GUIDING TUBE MODIFICATION.
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