FDA.reportPublic FDA data

PMA P040027S060

Device
Gore Viatorr Tips Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S060
Product code
MIR
Decision date
2018-05-18
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
Implementation of an alternate resin and updates to the specifications and sampling plan used in manufacture of the zipper fiber component of the GORE VIATORR TIPS Endoprosthesis and GORE 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
S060
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2018-05-18
Decision code
OK30
Date received
2018-04-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an alternate resin and updates to the specifications and sampling plan used in manufacture of the zipper fiber component of the GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion.