PMA P040043S023
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S023
- Product code
- MIH
- Decision date
- 2008-08-20
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE DISTRIBUTION OF THE 2008 ANNUAL CLINICAL UPDATE TO PHYSICIAN USERS FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S023
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-08-20
- Decision code
- APPR
- Date received
- 2008-05-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE DISTRIBUTION OF THE 2008 ANNUAL CLINICAL UPDATE TO PHYSICIAN USERS FOR THE DEVICE.