- Device
- GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S104
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2022-12-15
- Decision code
- APPR
- Date received
- 2022-11-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for minor modifications to the instructions for use and labeling to align with ISO 4971:2019 and to update the device storage conditions.