PMA P050006S087
- Device
- GORE CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S087
- Product code
- MLV
- Decision date
- 2020-12-04
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Modifications to the automated inspection equipment used during packaging inspection of the device.
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S087
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2020-12-04
- Decision code
- OK30
- Date received
- 2020-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the automated inspection equipment used during packaging inspection of the device.