PMA P030011S096
- Device
- SynCardia Total Artificial Heart (STAH) system
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S096
- Product code
- LOZ
- Decision date
- 2025-12-17
- Classification
- Cardiovascular
- Generic name
- Artificial heart
- Approval order statement
- Approval for alternate battery pack cells and cell separator used in the Freedom Driver.
Current openFDA PMA Record#
- Device
- SynCardia Total Artificial Heart (STAH) system
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S096
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2025-12-17
- Decision code
- APPR
- Date received
- 2025-09-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for alternate battery pack cells and cell separator used in the Freedom Driver.