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: GORE VIATORR TIPS ENDOPROSTHESIS
• Generic Name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Applicant: W. L. GORE & ASSOCIATES, INC.; 32360 N NORTH VALLEY PARKWAY; PHOENIX, AZ 85085
• PMA Number: P040027
• Supplement Number: S028
• Date Received: 05/01/2012
• Decision Date: 05/30/2012
• Product Code: MIR
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.