SynCardia temporary Total Artificial Heart (TAH-t) System

Artificial Heart

FDA Premarket Approval P030011 S074

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to update labeling in the freedom driver system manuals and clinical training slides

DeviceSynCardia temporary Total Artificial Heart (TAH-t) System
Classification NameArtificial Heart
Generic NameArtificial Heart
ApplicantSYNCARDIA SYSTEMS, LLC
Date Received2019-10-28
Decision Date2019-11-26
PMAP030011
SupplementS074
Product CodeLOZ
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SYNCARDIA SYSTEMS, LLC 1992 E. Silverlake Rd. tucson, AZ 85713

Supplemental Filings

Supplement NumberDateSupplement Type
P030011Original Filing
S074 2019-10-28 Special (immediate Track)
S073 2019-07-16 Special (immediate Track)
S072
S071 2019-06-18 30-day Notice
S070
S069 2019-05-28 30-day Notice
S068 2019-03-06 Real-time Process
S067 2019-01-22 30-day Notice
S066 2018-12-10 30-day Notice
S065 2018-11-19 30-day Notice
S064
S063
S062 2018-06-14 30-day Notice
S061 2018-03-30 30-day Notice
S060 2018-02-16 30-day Notice
S059 2017-11-14 30-day Notice
S058 2017-11-01 30-day Notice
S057 2017-11-01 Special (immediate Track)
S056 2017-09-01 30-day Notice
S055 2017-05-08 Real-time Process
S054 2017-04-07 135 Review Track For 30-day Notice
S053
S052 2017-03-16 30-day Notice
S051 2017-03-13 135 Review Track For 30-day Notice
S050 2017-03-03 135 Review Track For 30-day Notice
S049 2017-03-02 Special (immediate Track)
S048 2017-02-24 Real-time Process
S047 2017-02-07 30-day Notice
S046 2016-09-07 Real-time Process
S045 2016-08-22 30-day Notice
S044 2016-05-13 Real-time Process
S043 2016-03-30 Special (immediate Track)
S042 2016-02-22 30-day Notice
S041 2016-02-22 30-day Notice
S040 2016-02-22 30-day Notice
S039 2016-01-21 Real-time Process
S038 2015-12-31 135 Review Track For 30-day Notice
S037 2015-12-11 30-day Notice
S036 2015-10-19 Special (immediate Track)
S035 2015-09-29 30-day Notice
S034 2015-08-05 Real-time Process
S033 2015-08-03 Real-time Process
S032 2015-07-31 Normal 180 Day Track No User Fee
S031 2015-06-29 30-day Notice
S030 2014-11-20 Real-time Process
S029 2014-09-03 30-day Notice
S028
S027 2014-08-04 Real-time Process
S026 2014-07-10 30-day Notice
S025 2014-04-18 Normal 180 Day Track No User Fee
S024 2014-04-03 Normal 180 Day Track
S023 2013-12-18 Real-time Process
S022 2013-11-13 30-day Notice
S021 2013-08-07 Normal 180 Day Track No User Fee
S020 2013-02-15 Normal 180 Day Track
S019 2013-02-11 135 Review Track For 30-day Notice
S018
S017
S016 2012-06-21 Normal 180 Day Track No User Fee
S015 2012-06-08 Real-time Process
S014
S013 2012-06-01 Real-time Process
S012 2012-04-09 135 Review Track For 30-day Notice
S011 2011-06-10 Normal 180 Day Track
S010 2011-01-25 30-day Notice
S009 2010-11-22 Normal 180 Day Track No User Fee
S008 2010-06-21 Normal 180 Day Track No User Fee
S007 2010-01-15 Normal 180 Day Track No User Fee
S006 2009-11-23 30-day Notice
S005
S004
S003 2008-06-10 Normal 180 Day Track No User Fee
S002 2007-04-26 30-day Notice
S001 2005-05-10 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00858000003008 P030011 002
00858000003114 P030011 011
00858000003107 P030011 011
00858000003077 P030011 011
00858000003121 P030011 020
00858000003084 P030011 020

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