PMA P040043S098
- Device
- Gore Tag Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S098
- Product code
- MIH
- Decision date
- 2018-03-21
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Implementation of a film wrapping machine for the manufacture of the sealing cuffs of the GORE EXCLUDER AAA Endoprosthesis and the GORE Conformable TAG Thoracic Endoprosthesis.
Current openFDA PMA Record#
- Device
- Gore Tag Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S098
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2018-03-21
- Decision code
- OK30
- Date received
- 2018-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a film wrapping machine for the manufacture of the sealing cuffs of the GORE EXCLUDER AAA Endoprosthesis and the GORE Conformable TAG Thoracic Endoprosthesis.