- Device
- GORE® CARDIOFORM ASD Occluder; GORE® CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S117
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2026-02-20
- Decision code
- OK30
- Date received
- 2026-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to update the inspection method for the guidewire slot feature for both the GORE® CARDIOFORM ASD Occluder and GORE® CARDIOFORM Septal Occluder