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 VIATORR TIPS ENDOPROSTHESIS
• Classification Name: shunt, portosystemic, endoprosthesis
• Generic Name: shunt, postosystemic, endoprosthesis
• Applicant: W.L. GORE & ASSOCIATES,INC
• PMA Number: P040027
• Supplement Number: S025
• Date Received: 09/30/2011
• Decision Date: 10/27/2011
• Product Code: MIR [ Registered Establishments with MIR ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Final product assembly at the firms phoenix location.