PMA P040043S087
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S087
- Product code
- MIH
- Decision date
- 2016-10-24
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S087
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2016-10-24
- Decision code
- OK30
- Date received
- 2016-10-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.