PMA P050006S107
- Device
- GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S107
- Product code
- MLV
- Decision date
- 2024-03-20
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the Continued F/u of the ASSURED Study
Current openFDA PMA Record#
- Device
- GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S107
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2024-03-20
- Decision code
- APPR
- Date received
- 2023-09-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the Continued F/u of the ASSURED Study