SynCardia temporary Total Artificial Heart (TAH-t) System
FDA premarket approval P030011/S064 · decided 2023-07-06
Approval details
- PMA number
- P030011
- Supplement
- S064
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2018-09-14
- Decision date
- 2023-07-06
- Days to decision
- 1756 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for changes to the labeling to reflect the findings of the INTERMACS Companion post-approval Study.
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