PMA P040043S092
- Device
- GORE TAG Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S092
- Product code
- MIH
- Decision date
- 2017-06-16
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Updates to bioburden action/alert limits for the Gore Cardioform Septal Occluder, Gore TAG Thoracic Endoprosthesis, and Gore Excluder AAA Endoprosthesis, as well as approval to reassess alert limits periodically according to the given protocol and report updated alert limits in future PMA annual reports.
Current openFDA PMA Record#
- Device
- GORE TAG Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S092
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2017-06-16
- Decision code
- OK30
- Date received
- 2017-05-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to bioburden action/alert limits for the Gore Cardioform Septal Occluder, Gore TAG Thoracic Endoprosthesis, and Gore Excluder AAA Endoprosthesis, as well as approval to reassess alert limits periodically according to the given protocol and report updated alert limits in future PMA annual reports.