SynCardia temporary Total Artificial Heart (TAH-t) System
FDA premarket approval P030011/S077 · decided 2020-05-01
Approval details
- PMA number
- P030011
- Supplement
- S077
- Supplement type
- Real-Time Process
- 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
- 2020-02-05
- Decision date
- 2020-05-01
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for making minor design changes to the resistors on the Companion 2 Main Printed Circuit Board Assembly (PCBA).
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