PMA P050006S099
- Device
- GORE CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S099
- Product code
- MLV
- Decision date
- 2022-05-09
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Use of Semi-Automated Eyelet Film Wrappers for the manufacturing of the GORE® CARDIOFORM Septal Occluder.
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S099
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2022-05-09
- Decision code
- OK30
- Date received
- 2022-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of Semi-Automated Eyelet Film Wrappers for the manufacturing of the GORE® CARDIOFORM Septal Occluder.