PMA P050006S105
- Device
- GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S105
- Product code
- MLV
- Decision date
- 2022-12-21
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Implementation of a new water purification system at the Kendrick Peak facility.
Current openFDA PMA Record#
- Device
- GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S105
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2022-12-21
- Decision code
- OK30
- Date received
- 2022-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new water purification system at the Kendrick Peak facility.