Syncardia Temporary Cardio West Total Artificial Heart (TAH-T)
FDA premarket approval P030011/S049 · decided 2017-03-31
Approval details
- PMA number
- P030011
- Supplement
- S049
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Syncardia Temporary Cardio West Total Artificial Heart (TAH-T)
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2017-03-02
- Decision date
- 2017-03-31
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for labeling changes to the Freedom Driver System.
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