PMA P030011S092
- Device
- Total Artificial Heart
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S092
- Product code
- LOZ
- Decision date
- 2024-11-25
- Classification
- Cardiovascular
- Generic name
- Artificial heart
- Approval order statement
- approval to change the trade name of the device.
Current openFDA PMA Record#
- Device
- Total Artificial Heart
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S092
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2024-11-25
- Decision code
- APPR
- Date received
- 2024-05-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval to change the trade name of the device.