Total Artificial Heart
FDA premarket approval P030011/S093 · decided 2025-11-19
Approval details
- PMA number
- P030011
- Supplement
- S093
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Total Artificial Heart
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2024-06-20
- Decision date
- 2025-11-19
- Days to decision
- 517 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for the addition of a cover to go over the CPC quick connector components between the Total Artificial Heart and the pneumatic drivers.
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