PMA P030011S081
- Device
- Total Artificial Heart
- Applicant
- Syncardia Systems, LLC
- Product code
- LOZ
- Decision date
- 2025-06-25
- Generic name
- Artificial heart
- Approval order statement
- Approval for the protocol for the SynCardia 50cc temporary Total Artificial Heart (TAH-t) Post Approval Study.
Current openFDA PMA Record#
- Device
- Total Artificial Heart
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S081
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2025-06-25
- Decision code
- APPR
- Date received
- 2022-08-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the protocol for the SynCardia 50cc temporary Total Artificial Heart (TAH-t) Post Approval Study.