Durata, Optisure

FDA Premarket Approval P950022 S140

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

For changes related to the high voltage passive (durata and optisure) cardiac leads mcrd component manufacturing and analytical testing

DeviceDurata, Optisure
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantAbbott Medical
Date Received2021-07-01
Decision Date2021-07-29
PMAP950022
SupplementS140
Product CodeLWS 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 15900 Valley View Court sylmar, CA 91335

Supplemental Filings

Supplement NumberDateSupplement Type
P950022Original Filing
S143 2022-07-14 30-day Notice
S142 2021-10-15 Normal 180 Day Track No User Fee
S141 2021-08-02 30-day Notice
S140 2021-07-01 30-day Notice
S139 2021-06-28 30-day Notice
S138 2021-03-12 30-day Notice
S137 2020-11-25 30-day Notice
S136 2020-10-21 30-day Notice
S135 2020-08-11 Real-time Process
S134 2020-06-01 30-day Notice
S133 2020-05-22 30-day Notice
S132 2020-05-08 Normal 180 Day Track No User Fee
S131 2020-03-12 Normal 180 Day Track No User Fee
S130 2020-02-27 30-day Notice
S129 2020-01-27 30-day Notice
S128 2019-09-27 30-day Notice
S127
S126 2018-11-30 30-day Notice
S125 2018-11-23 30-day Notice
S124 2018-11-20 30-day Notice
S123 2018-10-02 30-day Notice
S122 2018-10-01 30-day Notice
S121 2018-09-28 30-day Notice
S120 2018-07-02 30-day Notice
S119 2018-04-02 Real-time Process
S118 2018-03-05 30-day Notice
S117 2018-02-27 30-day Notice
S116 2018-02-26 30-day Notice
S115 2018-01-31 30-day Notice
S114 2018-01-26 30-day Notice
S113 2017-12-21 30-day Notice
S112
S111 2017-09-22 30-day Notice
S110 2017-07-28 Real-time Process
S109 2017-07-03 Normal 180 Day Track
S108 2017-06-27 30-day Notice
S107 2017-06-16 Normal 180 Day Track
S106 2017-05-24 30-day Notice
S105 2017-04-03 Normal 180 Day Track
S104 2017-02-28 30-day Notice
S103 2017-02-24 30-day Notice
S102 2017-02-17 135 Review Track For 30-day Notice
S101 2017-02-10 30-day Notice
S100 2017-01-26 30-day Notice
S099 2017-01-25 30-day Notice
S098 2016-12-13 30-day Notice
S097 2016-11-08 30-day Notice
S096 2016-10-12 30-day Notice
S095 2016-09-27 135 Review Track For 30-day Notice
S094
S093 2016-06-22 30-day Notice
S092 2016-04-12 30-day Notice
S091 2016-01-19 30-day Notice
S090 2015-12-15 30-day Notice
S089 2015-10-26 135 Review Track For 30-day Notice
S088 2015-08-10 30-day Notice
S087 2014-09-29 30-day Notice
S086 2013-05-02 30-day Notice
S085 2012-10-24 Normal 180 Day Track
S084 2012-09-13 30-day Notice
S083 2012-09-05 Real-time Process
S082
S081 2012-01-09 135 Review Track For 30-day Notice
S080 2011-11-30 135 Review Track For 30-day Notice
S079 2011-11-07 Normal 180 Day Track
S078 2011-09-20 Real-time Process
S077 2011-06-20 Real-time Process
S076 2011-01-27 30-day Notice
S075 2010-10-21 Real-time Process
S074 2010-08-16 Normal 180 Day Track No User Fee
S073 2010-07-13 Normal 180 Day Track No User Fee
S072 2010-06-30 135 Review Track For 30-day Notice
S071 2010-06-15 30-day Notice
S070 2010-04-30 Real-time Process
S069 2010-04-22 Normal 180 Day Track
S068 2009-12-24 30-day Notice
S067 2009-11-25 Normal 180 Day Track No User Fee
S066
S065
S064 2009-08-28 30-day Notice
S063 2009-08-04 Real-time Process
S062 2009-06-10 30-day Notice
S061 2009-06-03 30-day Notice
S060 2009-05-14 Real-time Process
S059
S058 2009-02-06 Normal 180 Day Track No User Fee
S057 2009-01-30 30-day Notice
S056 2009-01-21 Normal 180 Day Track No User Fee
S055 2009-01-14 135 Review Track For 30-day Notice
S054 2008-09-29 135 Review Track For 30-day Notice
S053 2008-05-21 30-day Notice
S052 2008-05-07 Real-time Process
S051 2008-02-01 Normal 180 Day Track No User Fee
S050 2008-01-15 30-day Notice
S049 2007-12-03 Normal 180 Day Track No User Fee
S048 2007-11-19 30-day Notice
S047 2007-11-19 30-day Notice
S046 2007-11-05 135 Review Track For 30-day Notice
S045 2007-10-19 Normal 180 Day Track No User Fee
S044
S043 2007-09-20 30-day Notice
S042 2007-09-05 Normal 180 Day Track
S041 2007-08-22 Real-time Process
S040 2007-07-06 Real-time Process
S039 2007-05-10 30-day Notice
S038 2007-05-09 30-day Notice
S037 2007-02-26 30-day Notice
S036 2007-02-26 30-day Notice
S035 2007-02-21 30-day Notice
S034 2006-12-19 Real-time Process
S033 2006-11-15 135 Review Track For 30-day Notice
S032 2006-11-02 Real-time Process
S031 2006-10-16 30-day Notice
S030 2006-06-05 Real-time Process
S029
S028 2006-02-13 Real-time Process
S027 2006-02-10 Real-time Process
S026 2005-08-15 30-day Notice
S025 2005-05-31 Normal 180 Day Track
S024 2005-04-21 Real-time Process
S023 2005-04-05 30-day Notice
S022 2005-04-05 30-day Notice
S021 2005-04-05 30-day Notice
S020 2005-04-05 30-day Notice
S019 2005-03-25 Real-time Process
S018 2004-03-11 Real-time Process
S017 2003-06-09 Real-time Process
S016 2002-12-31 Real-time Process
S015 2002-12-04 Real-time Process
S014 2002-01-31 Real-time Process
S013 2001-08-10 Normal 180 Day Track
S012 2000-12-19 30-day Notice
S011 2000-08-17 Normal 180 Day Track
S010 2000-08-11 Normal 180 Day Track
S009 2000-06-08 Real-time Process
S008 2000-03-20 30-day Notice
S007 1999-12-14 Real-time Process
S006 1999-05-24 Normal 180 Day Track
S005 1999-02-08 Normal 180 Day Track
S004 1998-11-23 Real-time Process
S003 1998-08-20 Normal 180 Day Track
S002 1997-04-14 Normal 180 Day Track
S001 1996-10-15 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05414734500333 P950022 014
05414734503174 P950022 042
05414734502818 P950022 042
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H75871306009 P950022 049
05414734502146 P950022 049
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05414734503273 P950022 060
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05414734504676 P950022 077
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05414734507363 P950022 085
05414734507370 P950022 085
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05414734507394 P950022 085
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05414734507448 P950022 085
05414734507455 P950022 085
05414734507462 P950022 085
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05414734507318 P950022 085
05414734507301 P950022 085
05414734507172 P950022 085
05414734507189 P950022 085
05414734507196 P950022 085
05414734507202 P950022 085
05414734507219 P950022 085
05414734507226 P950022 085
05414734507233 P950022 085
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05414734507264 P950022 085
05414734507271 P950022 085
05414734507288 P950022 085
05414734507295 P950022 085
05414734507486 P950022 085

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