PMA P030011S077
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- Product code
- LOZ
- Decision date
- 2020-05-01
- Generic name
- Artificial heart
- Approval order statement
- Approval for making minor design changes to the resistors on the Companion 2 Main Printed Circuit Board Assembly (PCBA).
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S077
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2020-05-01
- Decision code
- APPR
- Date received
- 2020-02-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for making minor design changes to the resistors on the Companion 2 Main Printed Circuit Board Assembly (PCBA).