PMA P030011S034
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S034
- Product code
- LOZ
- Decision date
- 2015-11-02
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- APPROVAL FOR A FIRMWARE UPGRADE TO THE SINGLE BOARD COMPUTER OF THECOMPANION 2 DRIVER SYSTEM.
Current openFDA PMA Record#
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S034
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2015-11-02
- Decision code
- APPR
- Date received
- 2015-08-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A FIRMWARE UPGRADE TO THE SINGLE BOARD COMPUTER OF THECOMPANION 2 DRIVER SYSTEM.