PMA P030011S070
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- Product code
- LOZ
- Decision date
- 2020-03-05
- Generic name
- Artificial heart
- Approval order statement
- Approval for marketing of the 50cc temporary Total Artificial Heart (TAH-t) device.
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S070
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2020-03-05
- Decision code
- APPR
- Date received
- 2019-06-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for marketing of the 50cc temporary Total Artificial Heart (TAH-t) device.