PMA P050006S094
- Device
- GORE CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S094
- Product code
- MLV
- Decision date
- 2021-08-13
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Modify the vertical and post-bake ovens used to manufacture delivery sheaths.
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S094
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2021-08-13
- Decision code
- OK30
- Date received
- 2021-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the vertical and post-bake ovens used to manufacture delivery sheaths.