PMA P030011
- Device
- SynCardia Temporary Total Artificial Heart (TAH-t) System – Freedom Driver System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S082
- Product code
- LOZ
- Decision date
- 2026-07-09
- Generic name
- Artificial heart
- Approval order statement
- supplier change of Freedom Driver injection molded parts
Current openFDA PMA Record#
- Device
- SynCardia Temporary Total Artificial Heart (TAH-t) System – Freedom Driver System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S099
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2026-07-09
- Decision code
- OK30
- Date received
- 2026-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- supplier change of Freedom Driver injection molded parts