PMA P040043S110
- Device
- GORE TAG Thoracic Endoprosthesis
- Applicant
- W. L. GORE & ASSOCIATES, INC.
- PMA number
- P040043
- Supplement
- S110
- Product code
- MIH
- Decision date
- 2019-10-02
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Approval order statement
- Which Requested Approval To Implement Changes To Your Divisional Bacterial Endotoxin Test Parameters Using The Limulus Amebocyte Lysate Test Methodology
Current openFDA PMA Record
- Device
- GORE TAG Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S110
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2019-10-02
- Decision code
- APPR
- Date received
- 2019-03-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement changes to your divisional bacterial endotoxin test parameters using the Limulus Amebocyte Lysate test methodology.