SynCardia temporary Total Artificial Heart (TAH-t) System
FDA premarket approval P030011/S070 · decided 2020-03-05
Approval details
- PMA number
- P030011
- Supplement
- S070
- 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
- 2019-06-03
- Decision date
- 2020-03-05
- Days to decision
- 276 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for marketing of the 50cc temporary Total Artificial Heart (TAH-t) device.
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