PMA P040027S005

Device
GORE VIATORR TIPS ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S005
Product code
MIR
Decision date
2007-06-14
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
CHANGE IN VENDOR FOR THE ACCESS SLEEVE COMPONENT OF THE GORE VIATORR TIPS ENDOPROSTHESIS DELIVERY SYSTEM.

Current openFDA PMA Record#

Device
GORE VIATORR TIPS ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S005
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2007-06-14
Decision code
OK30
Date received
2007-05-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN VENDOR FOR THE ACCESS SLEEVE COMPONENT OF THE GORE VIATORR TIPS ENDOPROSTHESIS DELIVERY SYSTEM.