- Device
- GORE CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S083
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2020-07-02
- Decision code
- APPR
- Date received
- 2020-06-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to the device Instructions For Use to add a warning related to risks associated with physician modification of the device before use.