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 VIABAHN VBX Balloon Expandable Endoprosthesis
• Generic Name: Iliac covered stent, arterial
• Applicant: W. L. Gore & Associates, Inc.; 3250 W. Kiltie Ln.; Flagstaff, AZ 86005
• PMA Number: P160021
• Supplement Number: S020
• Date Received: 03/12/2019
• Decision Date: 10/02/2019
• Product Code: PRL
• Advisory Committee: Cardiovascular
• Supplement Type: 135 Review Track For 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to implement changes to your divisional bacterial endotoxin test parameters using the Limulus Amebocyte Lysate test methodology.