PMA P040027S050

Device: GORE VIATORR TIPS ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S050
Product code: MIR
Decision date: 2016-10-05
Classification: Shunt, Portosystemic, Endoprosthesis
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: Implementation of an alternate vacuum bond oven for use during manufacturing of the VIATORR TIPS Endoprosthesis and VIATORR TIPS Endoprosthesis with Controlled Expansion.

Current openFDA PMA Record#

Device: GORE VIATORR TIPS ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S050
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2016-10-05
Decision code: OK30
Date received: 2016-09-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an alternate vacuum bond oven for use during manufacturing of the VIATORR TIPS Endoprosthesis and VIATORR TIPS Endoprosthesis with Controlled Expansion.