PMA P030011S057
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System / Companion 2 Driver System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S057
- Product code
- LOZ
- Decision date
- 2017-12-08
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Approval for changes to the labeling of 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
- S057
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2017-12-08
- Decision code
- APPR
- Date received
- 2017-11-01
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the labeling of the Companion 2 Driver System.