Total Artificial Heart
FDA premarket approval P030011/S092 · decided 2024-11-25
Approval details
- PMA number
- P030011
- Supplement
- S092
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Total Artificial Heart
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2024-05-29
- Decision date
- 2024-11-25
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- approval to change the trade name of the device.
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