PMA P040043S067
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S067
- Product code
- MIH
- Decision date
- 2014-10-21
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE LABELING FOR THE GORE TAG THORACICENDOPROSTHESIS TO REFLECT THE FINDINGS OF THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S067
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-10-21
- Decision code
- APPR
- Date received
- 2014-07-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE LABELING FOR THE GORE TAG THORACICENDOPROSTHESIS TO REFLECT THE FINDINGS OF THE POST-APPROVAL STUDY.