PMA P040043S095
- Device
- GORE TAG Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S095
- Product code
- MIH
- Decision date
- 2017-09-27
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.
Current openFDA PMA Record#
- Device
- GORE TAG Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S095
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2017-09-27
- Decision code
- OK30
- Date received
- 2017-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.