SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

Artificial Heart

FDA Premarket Approval P030011 S007

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 for the trade name change of the subject device. The device will be marketed under the trade name syncardia temporary total artificial heart and is indicated for use in transplant-eligible candidates in imminent danger of death from irreversible biventricular failure.

DeviceSYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
Classification NameArtificial Heart
Generic NameArtificial Heart
ApplicantSYNCARDIA SYSTEMS, LLC
Date Received2010-01-15
Decision Date2010-04-28
PMAP030011
SupplementS007
Product CodeLOZ
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
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
S082 2022-08-23 30-day Notice
S081
S080
S079 2020-09-30 30-day Notice
S078 2020-02-12 30-day Notice
S077
S076 2019-12-23 30-day Notice
S075
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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