PMA P040043S045
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S045
- Product code
- MIH
- Decision date
- 2012-03-16
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR AN ALTERNATE FLUORINATED ETHYLENE PROPYLENE (FEP) RESIN AND AN ALTERNATE SUPPLIER FOR THE FEP FILM. THE SUPPLEMENT ALSO REQUESTED APPROVAL FOR A CHANGE TO THE SPECIFICATIONS OF THE FEP FILM. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME IDENTIFIED.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S045
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-03-16
- Decision code
- APPR
- Date received
- 2012-02-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE FLUORINATED ETHYLENE PROPYLENE (FEP) RESIN AND AN ALTERNATE SUPPLIER FOR THE FEP FILM. THE SUPPLEMENT ALSO REQUESTED APPROVAL FOR A CHANGE TO THE SPECIFICATIONS OF THE FEP FILM. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME IDENTIFIED.