SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
FDA premarket approval P030011/S033 · decided 2015-10-22
Approval details
- PMA number
- P030011
- Supplement
- S033
- 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
- 2015-08-03
- Decision date
- 2015-10-22
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR A MATERIAL CHANGE TO THE DRIVELINE TUBING OF THE FREEDOM DRIVER SYSTEM.
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