PMA P040043S082
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S082
- Product code
- MIH
- Decision date
- 2016-03-02
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Implement a new sewing machine to process the sleeve component of the GORE TAG Thoracic Endoprosthesis.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S082
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2016-03-02
- Decision code
- OK30
- Date received
- 2016-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a new sewing machine to process the sleeve component of the GORE TAG Thoracic Endoprosthesis.