- Device
- GORE CARDIOFORM Septal Occulder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S075
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2019-10-02
- Decision code
- APPR
- Date received
- 2019-03-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement changes to your divisional bacterial endotoxin test parameters using the Limulus Amebocyte Lysate test methodology.