PMA P030011S087
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S087
- Product code
- LOZ
- Decision date
- 2023-10-18
- Classification
- Cardiovascular
- Generic name
- Artificial heart
- Approval order statement
- change in the roller mixer used to produce components for the Syncardia TAH-t
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S087
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2023-10-18
- Decision code
- OK30
- Date received
- 2023-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change in the roller mixer used to produce components for the Syncardia TAH-t