Premarket Approval (PMA)

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.

• Device: BARD FLAIR ENDOVASCULAR STENT GRAFT
• Generic Name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
• Applicant: Bard Peripheral Vascular; 1625 W Third St.; Tempe, AZ 85281
• PMA Number: P060002
• Supplement Number: S005
• Date Received: 07/22/2009
• Decision Date: 09/04/2009
• Withdrawal Date: 09/12/2022
• Product Code: PFV
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.