PMA P040043S048
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S048
- Product code
- MIH
- Decision date
- 2012-05-30
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S048
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-05-30
- Decision code
- OK30
- Date received
- 2012-05-01
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.