PMA P040027S063

Device
GORE VIATORR TIPS Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S063
Product code
MIR
Decision date
2018-07-02
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
Update for device component manufacturing equipment.

Current openFDA PMA Record#

Device
GORE VIATORR TIPS Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S063
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2018-07-02
Decision code
OK30
Date received
2018-06-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update for device component manufacturing equipment.