FDA.reportPublic FDA data

PMA P040027S059

Device
GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S059
Product code
MIR
Decision date
2017-10-10
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
Use of additional machines for the manufacturing of the delivery systems for the GORE VIATORR TIPS Endoprosthesis with and without Controlled Expansion and the GORE VIABAHN Endoprosthesis with and without Heparin Bioactive Surface.

Current openFDA PMA Record#

Device
GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S059
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2017-10-10
Decision code
OK30
Date received
2017-09-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of additional machines for the manufacturing of the delivery systems for the GORE VIATORR TIPS Endoprosthesis with and without Controlled Expansion and the GORE VIABAHN Endoprosthesis with and without Heparin Bioactive Surface.