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: ANCURE ENDOGRAFT SYSTEM
• Classification Name: system, endovascular graft, aortic aneurysm treatment
• Generic Name: endovascular grafting system
• Applicant: GUIDANT CORP.
• PMA Number: P990017
• Supplement Number: S009
• Date Received: 09/21/2000
• Decision Date: 01/19/2001
• Product Code: MIH [ Registered Establishments with MIH ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for modifications to the ancure system instructions for use.