PMA P030011S093
- Device
- Total Artificial Heart
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S093
- Product code
- LOZ
- Decision date
- 2025-11-19
- Classification
- Cardiovascular
- Generic name
- Artificial heart
- Approval order statement
- Approval for the addition of a cover to go over the CPC quick connector components between the Total Artificial Heart and the pneumatic drivers.
Current openFDA PMA Record#
- Device
- Total Artificial Heart
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S093
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2025-11-19
- Decision code
- APPR
- Date received
- 2024-06-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of a cover to go over the CPC quick connector components between the Total Artificial Heart and the pneumatic drivers.