PMA P020004S183
- Device
- GORE EXCLUDER AAA Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S183
- Product code
- MIH
- Decision date
- 2021-08-13
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Modify the vertical and post-bake ovens used to manufacture delivery sheaths.
Current openFDA PMA Record#
- Device
- GORE EXCLUDER AAA Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S183
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-08-13
- Decision code
- OK30
- Date received
- 2021-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the vertical and post-bake ovens used to manufacture delivery sheaths.