PMA P030011S039
- Device
- SYNCARDIA CAMPANION 2 DRIVER SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S039
- Product code
- LOZ
- Decision date
- 2016-04-15
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Approval for a design change in the power cord.
Current openFDA PMA Record#
- Device
- SYNCARDIA CAMPANION 2 DRIVER SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S039
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2016-04-15
- Decision code
- APPR
- Date received
- 2016-01-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change in the power cord.