PMA P050006S112
- Device
- GORE CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S112
- Product code
- MLV
- Decision date
- 2024-10-09
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Approval for updates to the Instructions for Use.
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S112
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2024-10-09
- Decision code
- APPR
- Date received
- 2024-09-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the Instructions for Use.