PMA P030011S044
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S044
- Product code
- LOZ
- Decision date
- 2016-07-05
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Approval for a minor change to the Freedom Driver Printed Circuit Board Assembly (PCBA) and addition of an alternate qualified supplier.
Current openFDA PMA Record#
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S044
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2016-07-05
- Decision code
- APPR
- Date received
- 2016-05-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a minor change to the Freedom Driver Printed Circuit Board Assembly (PCBA) and addition of an alternate qualified supplier.