Premarket Approval (PMA)

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.

• Trade Name: BARD FLAIR ENDOVASCULAR STENT GRAFT
• Classification Name: system, endovascular graft, aortic aneurysm treatment
• Generic Name: endoprosthesis
• Applicant: C.R. BARD, INC.
• PMA Number: P060002
• Supplement Number: S006
• Date Received: 09/30/2009
• Decision Date: 05/18/2010
• Product Code: MIH [ Registered Establishments with MIH ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval protocol.