SynCardia temporary Total Artificial Heart (TAH-t) System
FDA premarket approval P030011/S068 · decided 2019-04-17
Approval details
- PMA number
- P030011
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2019-03-06
- Decision date
- 2019-04-17
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for extension of the use by date for the External Battery of the Companion 2 Driver.
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