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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 NumberS028
Date Received09/27/2012
Decision Date10/04/2012
Withdrawal Date09/12/2022
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 FOR THE INCORPORATION OF A NEW LEICA DM2500M MICROSCOPE AND DFC295 DIGITAL CAMERA TO INCREASE IMAGE RESOLUTION IN ORDER TO MEASURE MATERIAL POROSITY IN ACCORDANCE WITH ISO 7198.
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