PMA P040043S069
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S069
- Product code
- MIH
- Decision date
- 2014-10-29
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S069
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-10-29
- Decision code
- OK30
- Date received
- 2014-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.