PMA P040027S084

Device: GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S084
Product code: MIR
Decision date: 2021-03-04
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: Implementation of an alternate manufacturing site to produce the ultra-thin walled component of the GORE VIATORR TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion.

Current openFDA PMA Record#

Device: GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S084
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2021-03-04
Decision code: OK30
Date received: 2021-02-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an alternate manufacturing site to produce the ultra-thin walled component of the GORE VIATORR TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion.