- Device
- GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S119
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2026-08-03
- Decision code
- APPR
- Date received
- 2026-07-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the Instructions for Use (IFU) for the GORE® CARDIOFORM Septal Occluder and GORE® CARDIOFORM ASD Occluder to add instructions of optional delivery system manipulation techniques in the event of a delayed lock has occurred at device deployment