PMA P030011S089

Device: SynCardia temporary Total Artificial Heart (TAH-t) System
Applicant: Syncardia Systems, LLC
PMA number: P030011
Supplement: S089
Product code: LOZ
Decision date: 2024-03-04
Classification: Cardiovascular
Generic name: Artificial heart
Approval order statement: Approval for a minor change to the Freedom Driver onboard battery service life evaluation criteria to extend the service life of the batteries.

Current openFDA PMA Record#

Device: SynCardia temporary Total Artificial Heart (TAH-t) System
Applicant: Syncardia Systems, LLC
PMA number: P030011
Supplement: S089
Product code: LOZ
Generic name: Artificial heart
Decision date: 2024-03-04
Decision code: APPR
Date received: 2024-01-23
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a minor change to the Freedom Driver onboard battery service life evaluation criteria to extend the service life of the batteries.