PMA P030011S071
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S071
- Product code
- LOZ
- Decision date
- 2019-07-18
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Change of a component supplier for the Companion 2 Driver System.
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
- S071
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2019-07-18
- Decision code
- OK30
- Date received
- 2019-06-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of a component supplier for the Companion 2 Driver System.