- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S076
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2020-01-22
- Decision code
- OK30
- Date received
- 2019-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of location for a component supplier with additional minor capacitor changes on PCBAs for the Companion 2 Hospital Cart and Driver Caddy.