FDA.reportPublic FDA data

PMA P040027S052

Device
GORE VIATORR TIPS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S052
Product code
MIR
Decision date
2016-11-29
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
Approval for an update to the Instructions for Use to indicate that in VIATORR® devices with controlled expansion, ultrasonic visualization of the lumen of the graft-lined region may be difficult through 7 days or greater post-implantation.

Current openFDA PMA Record#

Device
GORE VIATORR TIPS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S052
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2016-11-29
Decision code
APPR
Date received
2016-11-07
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for an update to the Instructions for Use to indicate that in VIATORR® devices with controlled expansion, ultrasonic visualization of the lumen of the graft-lined region may be difficult through 7 days or greater post-implantation.