FDA.reportPublic FDA data

PMA P040043S119

Device
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S119
Product code
MIH
Decision date
2020-09-02
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Implementation of water leakage evaluation, as a secondary test, in Quality Control testing of Gore TAG Conformable Thoracic Stent Graft with Active Control System.

Current openFDA PMA Record#

Device
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S119
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-09-02
Decision code
OK30
Date received
2020-08-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of water leakage evaluation, as a secondary test, in Quality Control testing of Gore TAG Conformable Thoracic Stent Graft with Active Control System.