Syncardia Systems L L C

FDA Filings

This page includes the latest FDA filings for Syncardia Systems L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003761017
• FEI Number: 3003761017
• Name: SYNCARDIA SYSTEMS, LLC
• Owner & Operator: SYNCARDIA SYSTEMS, LLC
• Contact Address: 1992 E. SILVERLAKE RD. ; Tucson AZ 85713 US
• Official Correspondent:
  • Kerri A Hensley
  • x-520-5451234-1206
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1992 E Silverlake Rd ; TUCSON, AZ 85713 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P030011S079 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart System	2020-10-28
Hand Sanitizer SynCardia Systems, LLC	Otc Medication	2020-04-18
Hand Sanitizer SynCardia Systems, LLC	Otc Medication	2020-04-15
NDC 74681-541 SynCardia Systems, LLC	Hand Sanitizer	2020-04-06
PMA P030011S078 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2020-03-12
PMA P030011S076 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2020-01-22
PMA P030011S074 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2019-11-26
PMA P030011S073 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2019-08-15
PMA P030011S071 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System	2019-07-18
PMA P030011S069 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2019-06-26
PMA P030011S068 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2019-04-17
PMA P030011S067 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artifical Heart (TAH-t) System	2019-02-20
PMA P030011S066 SYNCARDIA SYSTEMS, LLC	Syncardia Temporary Total Artificial Heart (TAH-T) system	2019-01-09
PMA P030011S065 SYNCARDIA SYSTEMS, LLC	SynCardia temporaty Total Artificial Heart (TAH-t) System	2018-12-17
GUDID 00858000003121 SYNCARDIA SYSTEMS, LLC	SynCardia Freedom® Driver	2018-07-06
GUDID 00858000003114 SYNCARDIA SYSTEMS, LLC	SynCardia Hand Pump	2018-07-06
GUDID 00858000003107 SYNCARDIA SYSTEMS, LLC	SynCardia Companion 2 Driver	2018-07-06
GUDID 00858000003084 SYNCARDIA SYSTEMS, LLC	SynCardia Freedom® Onboard Battery	2018-07-06
GUDID 00858000003077 SYNCARDIA SYSTEMS, LLC	SynCardia Companion Rechargeable LI-ION Battery	2018-07-06
GUDID 00858000003008 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart System	2018-07-06
PMA P030011S062 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System	2018-07-04
PMA P030011S051 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t)	2018-05-02
PMA P030011S061 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System	2018-04-25
PMA P030011S060 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM	2018-03-16
PMA P030011S057 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System / Companion 2 Driver System	2017-12-08
PMA P030011S059 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2017-12-07
PMA P030011S050 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-T) System	2017-12-06
PMA P030011S058 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System; Freedom Driver System	2017-12-01
PMA P030011S056 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2017-09-29
PMA P030011S055 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2017-06-09
PMA P030011S048 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2017-05-24
PMA P030011S054 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2017-05-12
PMA P030011S052 SYNCARDIA SYSTEMS, LLC	SynCardia temporary Total Artificial Heart (TAH-t) System	2017-04-04
PMA P030011S049 SYNCARDIA SYSTEMS, LLC	Syncardia Temporary Cardio West Total Artificial Heart (TAH-T)	2017-03-31
PMA P030011S047 SYNCARDIA SYSTEMS, LLC	SynCardia Temporary Total Artificial Heart	2017-03-09
PMA P030011S046 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2016-10-12
PMA P030011S045 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2016-09-21
PMA P030011S044 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM	2016-07-05
PMA P030011S043 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)	2016-04-27
PMA P030011S039 SYNCARDIA SYSTEMS, LLC	SYNCARDIA CAMPANION 2 DRIVER SYSTEM	2016-04-15
PMA P030011S041 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)	2016-03-22
PMA P030011S040 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)	2016-03-22
PMA P030011S042 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)	2016-03-17
PMA P030011S038 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2016-02-22
PMA P030011S037 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2016-01-07
PMA P030011S036 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2015-12-09
PMA P030011S032 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2015-11-27
PMA P030011S034 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2015-11-02
PMA P030011S035 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2015-10-29
PMA P030011S033 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2015-10-22
PMA P030011S031 SYNCARDIA SYSTEMS, LLC	FREEDOM DRIVER SYSTEM	2015-07-29
PMA P030011S030 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2015-02-12
PMA P030011S029 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2014-09-29
PMA P030011S027 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2014-09-12
PMA P030011S026 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2014-08-07
PMA P030011S024 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2014-07-02
PMA P030011S020 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2014-06-26
PMA P030011S025 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)	2014-06-20
PMA P030011S023 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2014-03-18
PMA P030011S021 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2013-12-24
PMA P030011S022 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2013-12-13
PMA P030011S019 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2013-05-30
PMA P030011S016 SYNCARDIA SYSTEMS, LLC	SYNCARDIA COMPANION 2 DRIVER SYSTEM	2012-08-20
PMA P030011S015 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2012-08-10
PMA P030011S013 SYNCARDIA SYSTEMS, LLC	SYNCARDIA COMPANION 2 DRIVER SYSTEM	2012-07-05
PMA P030011S012 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2012-06-26
PMA P030011S011 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2012-05-16
PMA P030011S010 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2011-02-18
PMA P030011S009 SYNCARDIA SYSTEMS, LLC	TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2011-01-04
PMA P030011S008 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2010-10-26
PMA P030011S007 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART	2010-04-28
PMA P030011S006 SYNCARDIA SYSTEMS, LLC	CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2009-12-23
PMA P030011S003 SYNCARDIA SYSTEMS, LLC	CARDIOWEST TEMPORARY TOTAL ARTIFICAL HEART (TAH-T) SYSTEM	2008-08-11
PMN P030011 | LOZ SYNCARDIA SYSTEMS, LLC	CardioWest TAH-t	2007-11-26
PMA P030011S002 SYNCARDIA SYSTEMS, LLC	CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM	2007-05-23
PMA P030011S001 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T)	2005-10-26
PMA P030011 SYNCARDIA SYSTEMS, LLC	SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)	2004-10-15

Similar & Related FDA Registered Companies

• SYNCARDIA SYSTEMS, LLC1992 E. Silverlake Rd.tucson, AZ 85713 PMA NumberP030011 Supplement NumberS082 Date Received08/23/2022 Decision Date09/22/2022 Product Code LOZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
201905095415	Stadersand,Federal Republic of Germany -> Los Angeles, California	MOCK TANKS HS CODE 90230080000 SCAC SSLL AMS REF LAX229582	1 CAS