PMA P030011S054
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S054
- Product code
- LOZ
- Decision date
- 2017-05-12
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Approval for a change of supplier for the Freedom Driver main Printed Circuit Board Assembly (PCBA).
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S054
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2017-05-12
- Decision code
- APPR
- Date received
- 2017-04-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change of supplier for the Freedom Driver main Printed Circuit Board Assembly (PCBA).