FDA.reportPublic FDA data

PMA P040043S115

Device
Gore TAG Thoracic Stent Graft with ACTIVE CONTROL System
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S115
Product code
MIH
Decision date
2020-07-09
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Implementation of updates to the sleeve trimming procedure and addition of inspection for damage to the deployment line of the GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System.

Current openFDA PMA Record#

Device
Gore TAG Thoracic Stent Graft with ACTIVE CONTROL System
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S115
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-07-09
Decision code
OK30
Date received
2020-06-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of updates to the sleeve trimming procedure and addition of inspection for damage to the deployment line of the GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System.