SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
FDA premarket approval P030011/S024 · decided 2014-07-02
Approval details
- PMA number
- P030011
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2014-04-03
- Decision date
- 2014-07-02
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR USE OF THE SYNHALL VALVE IN THE SYNCARDIA TEMPORARY TOTALARTIFICIAL HEART (TAH-T).
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