PMA P040027S029

Device: GORE VIATORR TIPS ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S029
Product code: MIR
Decision date: 2013-05-02
Classification: Shunt, Portosystemic, Endoprosthesis
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: ALTERNATE FEP FILM SUPPLIER AND A CHANGE FROM IN-PROCESS TESTING TO THE RAWMATERIAL TESTING FOR CERTAIN TESTS PERFORMED BY THE NEW QUALIFIED SUPPLIER.

Current openFDA PMA Record#

Device: GORE VIATORR TIPS ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S029
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2013-05-02
Decision code: OK30
Date received: 2013-04-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE FEP FILM SUPPLIER AND A CHANGE FROM IN-PROCESS TESTING TO THE RAWMATERIAL TESTING FOR CERTAIN TESTS PERFORMED BY THE NEW QUALIFIED SUPPLIER.