PMA P050006S084
- Device
- GORE CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S084
- Product code
- MLV
- Decision date
- 2020-08-06
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Approval for implementing a change to the colorant in the coating of the impacted components.
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S084
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2020-08-06
- Decision code
- APPR
- Date received
- 2020-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for implementing a change to the colorant in the coating of the impacted components.