Total Artificial Heart
FDA premarket approval P030011/S081 · decided 2025-06-25
Approval details
- PMA number
- P030011
- Supplement
- S081
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Total Artificial Heart
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2022-08-10
- Decision date
- 2025-06-25
- Days to decision
- 1050 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for the protocol for the SynCardia 50cc temporary Total Artificial Heart (TAH-t) Post Approval Study.
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