PMA P030011S062
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S062
- Product code
- LOZ
- Decision date
- 2018-07-04
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Change of manufacturer for the electrical assemblies for the Companion 2 Driver.
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S062
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2018-07-04
- Decision code
- OK30
- Date received
- 2018-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of manufacturer for the electrical assemblies for the Companion 2 Driver.