PMA P030011S064
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- Product code
- LOZ
- Decision date
- 2023-07-06
- Generic name
- Artificial heart
- Approval order statement
- Approval for changes to the labeling to reflect the findings of the INTERMACS Companion post-approval Study.
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S064
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2023-07-06
- Decision code
- APPR
- Date received
- 2018-09-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for changes to the labeling to reflect the findings of the INTERMACS Companion post-approval Study.