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Devices
SynCardia Freedom Driver System
Model / Serial
S/N 5002 UDI (01)00858000003121(21)5002 S/N 5005 UDI (01)00858000003121(21)5005 S/N 5008 UDI (01)00858000003121(21)5008 S/N 5009 UDI (01)00858000003121(21)5009 S/N 5010 UDI (01)00858000003121(21)5010
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
US distribution to Virginia and Arizona.
Product Description
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Manufacturer
SynCardia Systems Inc.
1 Event
Recall of SynCardia Freedom Driver System
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Manufacturer
SynCardia Systems Inc.
Manufacturer Address
SynCardia Systems Inc., 1992 E Silverlake Rd, Tucson AZ 85713-3865
Manufacturer Parent Company (2017)
Tah Windown Inc.
Source
USFDA
2 devices with a similar name
Learn more about the data
here
SynCardia Freedom Driver System
Model / Serial
Implanted device?
Yes
Product Description
Active implantable medical devices - artificial hearts
Manufacturer
SynCardia Systems Inc.
SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart Sy...
Model / Serial
SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)Product Code: SYN-595000-001Supplied through Clinical Trial and SAS Category A
Manufacturer
Device Technologies Australia Pty Ltd
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