PMA P040027S014

Device
GORE VIATORR TIPS ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S014
Product code
MIR
Decision date
2009-04-07
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
EQUIPMENT MODIFICATION TO INCREASE THE CAPACITY AT AN IN-PROCESS WORK STEP.

Current openFDA PMA Record#

Device
GORE VIATORR TIPS ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S014
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2009-04-07
Decision code
OK30
Date received
2009-03-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
EQUIPMENT MODIFICATION TO INCREASE THE CAPACITY AT AN IN-PROCESS WORK STEP.