PMA P040043S017
- Device
- GORE TAG THORACIC ENDOPROTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S017
- Product code
- MIH
- Decision date
- 2008-02-25
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE MODIFICATIONS TO MANUFACTURING TOOLS AND THE CRUSH/TRANSFER LOADING PROCESS.
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S017
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-02-25
- Decision code
- APPR
- Date received
- 2007-08-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE MODIFICATIONS TO MANUFACTURING TOOLS AND THE CRUSH/TRANSFER LOADING PROCESS.