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PMA P040027S066

Device
GORE VIATORR Tips Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S066
Product code
MIR
Decision date
2018-09-26
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
Updates to bioburden action/alert limits for the GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access) and GORE VIATORR Tips Endoprosthesis, as well as approval to reassess alert limits periodically according to the given protocol and report updated alert limits in future PMA annual reports.

Current openFDA PMA Record#

Device
GORE VIATORR Tips Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S066
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2018-09-26
Decision code
OK30
Date received
2018-08-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to bioburden action/alert limits for the GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access) and GORE VIATORR Tips Endoprosthesis, as well as approval to reassess alert limits periodically according to the given protocol and report updated alert limits in future PMA annual reports.