SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
FDA premarket approval P030011/S020 · decided 2014-06-26
Approval details
- PMA number
- P030011
- Supplement
- S020
- 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
- 2013-02-15
- Decision date
- 2014-06-26
- Days to decision
- 496 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR THE FREEDOM® DRIVER SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART WITH THE FREEDOM® DRIVER SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES WHO HAVE BEEN IMPLANTED WITH THE TAH-T AND ARE CLINICALLY STABLE.
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