FDA.reportPublic FDA data

PMA P040043S117

Device
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S117
Product code
MIH
Decision date
2020-08-05
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Implementation of an alternate manufacturing process for the primary tubular sleeve component 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
S117
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-08-05
Decision code
OK30
Date received
2020-07-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an alternate manufacturing process for the primary tubular sleeve component of the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System.