PMA P040027S041

Device: GORE VIATORR TIPS ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S041
Product code: MIR
Decision date: 2015-04-03
Classification: Shunt, Portosystemic, Endoprosthesis
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: CHANGE TO THE WATER ENTRY PRESSURE (WEP) TESTING REQUIREMENT FOR THE GRAFT COMPONENTS OF THE GORE VIATORR TIPS ENDOPROSTHESIS FROM A LOT ACCEPTANCE TEST TO A QUALIFICATION TEST.

Current openFDA PMA Record#

Device: GORE VIATORR TIPS ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S041
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2015-04-03
Decision code: OK30
Date received: 2015-03-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE WATER ENTRY PRESSURE (WEP) TESTING REQUIREMENT FOR THE GRAFT COMPONENTS OF THE GORE VIATORR TIPS ENDOPROSTHESIS FROM A LOT ACCEPTANCE TEST TO A QUALIFICATION TEST.