PMA P040043S060
- Device
- GODRE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S060
- Product code
- MIH
- Decision date
- 2014-06-04
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE DESTRUCTIVE TESTING SAMPLING PLAN AND CHANGE IN THE DEPLOYMENT FORCE SPECIFICATION.
Current openFDA PMA Record#
- Device
- GODRE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S060
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-06-04
- Decision code
- APPR
- Date received
- 2014-01-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE DESTRUCTIVE TESTING SAMPLING PLAN AND CHANGE IN THE DEPLOYMENT FORCE SPECIFICATION.