SynCardia temporary Total Artificial Heart (TAH-t) System
FDA premarket approval P030011/S084 · decided 2023-04-12
Approval details
- PMA number
- P030011
- Supplement
- S084
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2023-02-02
- Decision date
- 2023-04-12
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for a software change to the cardiac output and fill volume calculations of the Freedom Driver.
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