SynCardia Total Artificial Heart (STAH) system
FDA premarket approval P030011/S096 · decided 2025-12-17
Approval details
- PMA number
- P030011
- Supplement
- S096
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SynCardia Total Artificial Heart (STAH) system
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2025-09-19
- Decision date
- 2025-12-17
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for alternate battery pack cells and cell separator used in the Freedom Driver.
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