PMA P030011S048
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S048
- Product code
- LOZ
- Decision date
- 2017-05-24
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Approval for a change in the length of screw used in the Freedom Driver.
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S048
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2017-05-24
- Decision code
- APPR
- Date received
- 2017-02-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the length of screw used in the Freedom Driver.