PMA P030011S042

Device: SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
Applicant: Syncardia Systems, LLC
PMA number: P030011
Supplement: S042
Product code: LOZ
Decision date: 2016-03-17
Classification: Artificial Heart
Generic name: Artificial heart
Approval order statement: Change to add three alternate, equivalent subcomponents (one capacitor, two resistors) on the Companion 2 Driver Main Printed Circuit Board Assembly (PCBA).

Current openFDA PMA Record#

Device: SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
Applicant: Syncardia Systems, LLC
PMA number: P030011
Supplement: S042
Product code: LOZ
Generic name: Artificial heart
Decision date: 2016-03-17
Decision code: OK30
Date received: 2016-02-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to add three alternate, equivalent subcomponents (one capacitor, two resistors) on the Companion 2 Driver Main Printed Circuit Board Assembly (PCBA).