FDA.reportPublic FDA data

PMA P040043S125

Device
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S125
Product code
MIH
Decision date
2021-04-08
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Implementation of a manufacturing aid during the Stent Graft Constraining step 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
S125
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2021-04-08
Decision code
OK30
Date received
2021-03-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a manufacturing aid during the Stent Graft Constraining step of the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System.