PMA P040027S016

Device
GORE VIATORR TIPS ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S016
Product code
MIR
Decision date
2009-07-30
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
RELOCATION OF THE MANUFACTURING OF THE DEVICE FROM ONE BUILDING TO ANOTHER WITHIN THE SAME CAMPUS.

Current openFDA PMA Record#

Device
GORE VIATORR TIPS ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S016
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2009-07-30
Decision code
OK30
Date received
2009-07-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
RELOCATION OF THE MANUFACTURING OF THE DEVICE FROM ONE BUILDING TO ANOTHER WITHIN THE SAME CAMPUS.