PMA P040027S056

Device: GORE, VIATORR TIPS Endoprosthesis - with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S056
Product code: MIR
Decision date: 2017-06-06
Classification: Shunt, Portosystemic, Endoprosthesis
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: Alternate supplier and the elimination of a redundant inspection for a component of the GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion.

Current openFDA PMA Record#

Device: GORE, VIATORR TIPS Endoprosthesis - with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S056
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2017-06-06
Decision code: OK30
Date received: 2017-05-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate supplier and the elimination of a redundant inspection for a component of the GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion.