FDA.reportPublic FDA data

PMA P040043S118

Device
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant
W. L. Gore & Associates, Inc.
Product code
MIH
Decision date
2020-10-05
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for the addition of a color additive to the secondary deployment line and sleeve attachment fibers of the 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
S118
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-10-05
Decision code
APPR
Date received
2020-07-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of a color additive to the secondary deployment line and sleeve attachment fibers of the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System.