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PMA P040027S069

Device
GORE VIATORR TIPS Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S069
Product code
MIR
Decision date
2019-01-02
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE TIGRIS Vascular Stent and GORE CARDIOFORM Septal Occluder.

Current openFDA PMA Record#

Device
GORE VIATORR TIPS Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S069
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2019-01-02
Decision code
OK30
Date received
2018-12-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE TIGRIS Vascular Stent and GORE CARDIOFORM Septal Occluder.