- Device
- GORE® CARDIOFORM ASD Occluder, GORE® CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S109
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2024-04-29
- Decision code
- APPR
- Date received
- 2024-01-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a change to the flush port tubing material that is a component of the Delivery Systems of the GORE® CARDIOFORM ASD Occluder and GORE® CARDIOFORM Septal Occluder