- Device
- GORE Cardioform Septal Occluder and GORE Cardioform ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S089
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2021-01-26
- Decision code
- OK30
- Date received
- 2021-01-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Site changes to the LAL testing requirement and removal of cytotoxicity and infrared spectroscopy inspections for incoming components.