SYNCARDIA SYSTEMS, LLC

FDA Filings

This page includes the latest FDA filings for SYNCARDIA SYSTEMS, LLC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2019-11-26
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2019-08-15
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System2019-07-18
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2019-06-26
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2019-04-17
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artifical Heart (TAH-t) System2019-02-20
SYNCARDIA SYSTEMS, LLC
Syncardia Temporary Total Artificial Heart (TAH-T) system2019-01-09
SYNCARDIA SYSTEMS, LLC
SynCardia temporaty Total Artificial Heart (TAH-t) System2018-12-17
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System2018-07-04
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t)2018-05-02
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System2018-04-25
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM2018-03-16
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System / Companion 2 Driver System2017-12-08
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-12-07
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-T) System2017-12-06
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System; Freedom Driver System2017-12-01
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-09-29
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-06-09
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-05-24
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-05-12
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-04-04
SYNCARDIA SYSTEMS, LLC
Syncardia Temporary Cardio West Total Artificial Heart (TAH-T)2017-03-31
SYNCARDIA SYSTEMS, LLC
SynCardia Temporary Total Artificial Heart2017-03-09
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2016-10-12
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2016-09-21
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM2016-07-05
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)2016-04-27
SYNCARDIA SYSTEMS, LLC
SYNCARDIA CAMPANION 2 DRIVER SYSTEM2016-04-15
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)2016-03-22
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)2016-03-22

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
SynCardia Freedom® Driver
SYNCARDIA SYSTEMS, LLC2018-07-06
SynCardia Hand Pump
SYNCARDIA SYSTEMS, LLC2018-07-06
SynCardia Companion 2 Driver
SYNCARDIA SYSTEMS, LLC2018-07-06
SynCardia Freedom® Onboard Battery
SYNCARDIA SYSTEMS, LLC2018-07-06
SynCardia Companion Rechargeable LI-ION Battery
SYNCARDIA SYSTEMS, LLC2018-07-06
SynCardia temporary Total Artificial Heart System
SYNCARDIA SYSTEMS, LLC2018-07-06

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