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: GORE EXCLUDER AAA ENDOPROSTHESIS
• Classification Name: system, endovascular graft, aortic aneurysm treatment
• Generic Name: endovascular graft
• Applicant: W.L. GORE & ASSOCIATES,INC
• PMA Number: P020004
• Supplement Number: S066
• Date Received: 10/07/2011
• Decision Date: 10/27/2011
• Product Code: MIH [ Registered Establishments with MIH ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Update in bacterial endotoxin testing software.