PMA P030011S038

Device: SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Applicant: Syncardia Systems, LLC
PMA number: P030011
Supplement: S038
Product code: LOZ
Decision date: 2016-02-22
Classification: Artificial Heart
Generic name: Artificial heart
Approval order statement: Approval for a location change for a secondary supplier as well as the addition of 3 new machines at the same secondary supplier.

Current openFDA PMA Record#

Device: SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Applicant: Syncardia Systems, LLC
PMA number: P030011
Supplement: S038
Product code: LOZ
Generic name: Artificial heart
Decision date: 2016-02-22
Decision code: APPR
Date received: 2015-12-31
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a location change for a secondary supplier as well as the addition of 3 new machines at the same secondary supplier.