SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM
FDA premarket approval P030011/S044 · decided 2016-07-05
Approval details
- PMA number
- P030011
- Supplement
- S044
- 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
- 2016-05-13
- Decision date
- 2016-07-05
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for a minor change to the Freedom Driver Printed Circuit Board Assembly (PCBA) and addition of an alternate qualified supplier.
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