PMA P040043S106
- Device
- GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. GORE & ASSOCIATES, INC.
- PMA number
- P040043
- Supplement
- S106
- Product code
- MIH
- Decision date
- 2019-05-14
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Approval order statement
- Approval For The Following:1) Modifications To The Delivery System;2) Implementation Of Six Additional Implant Lengths;3) Reduction In Profile For A Subset Of Device Sizes; And4) Updates To The Instructions For Use To Reflect The Changes In The Device Design And Directions For Use.
Current openFDA PMA Record
- Device
- GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S106
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2019-05-14
- Decision code
- APPR
- Date received
- 2018-11-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the following:1) Modifications to the delivery system;2) Implementation of six additional implant lengths;3) Reduction in profile for a subset of device sizes; and4) Updates to the Instructions for Use to reflect the changes in the device design and directions for use.