SynCardia temporary Total Artificial Heart (TAH-t) System
FDA premarket approval P030011/S080 · decided 2022-11-22
Approval details
- PMA number
- P030011
- Supplement
- S080
- Supplement type
- Normal 180 Day Track
- 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
- 2022-06-21
- Decision date
- 2022-11-22
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for alternate Companion 2 battery printed circuit board assembly (PCBA) sub-components and a new mold for a component of the battery assembly.
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