LATITUDE Programming System

Implantable Cardioverter Defibrillator (non-crt)

FDA Premarket Approval P910077 S175

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

To add a new functional tester to the model 3300 latitude programming sytem manufacturing line

DeviceLATITUDE Programming System
Classification NameImplantable Cardioverter Defibrillator (non-crt)
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2019-10-28
Decision Date2019-11-26
PMAP910077
SupplementS175
Product CodeLWS
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P910077Original Filing
S175 2019-10-28 30-day Notice
S174
S173 2019-07-22 Real-time Process
S172 2019-04-10 Real-time Process
S171 2019-03-20 Real-time Process
S170 2019-03-13 30-day Notice
S169
S168 2018-12-03 Real-time Process
S167 2018-07-18 Normal 180 Day Track No User Fee
S166 2018-03-26 30-day Notice
S165 2018-01-18 Real-time Process
S164 2017-12-14 Real-time Process
S163 2017-10-20 Real-time Process
S162 2017-09-15 Real-time Process
S161 2017-05-26 Normal 180 Day Track
S160 2017-05-22 Real-time Process
S159 2017-04-03 Normal 180 Day Track
S158 2017-02-17 Real-time Process
S157 2016-11-22 Real-time Process
S156 2016-10-26 Normal 180 Day Track
S155 2016-10-19 Normal 180 Day Track
S154 2016-06-16 Normal 180 Day Track
S153 2016-05-27 30-day Notice
S152 2016-04-21 Real-time Process
S151 2015-12-21 Real-time Process
S150 2015-06-29 30-day Notice
S149 2015-04-27 Real-time Process
S148 2014-11-20 Real-time Process
S147 2014-09-05 Real-time Process
S146 2014-08-15 30-day Notice
S145 2014-06-30 30-day Notice
S144 2014-06-09 Real-time Process
S143 2014-05-27 Real-time Process
S142 2014-04-22 30-day Notice
S141 2014-02-21 Real-time Process
S140 2013-11-20 Normal 180 Day Track
S139 2013-09-30 Normal 180 Day Track
S138 2013-09-25 Normal 180 Day Track
S137 2013-08-29 30-day Notice
S136 2013-07-22 30-day Notice
S135 2013-05-23 30-day Notice
S134 2013-05-17 Real-time Process
S133 2013-05-16 Real-time Process
S132 2013-02-12 30-day Notice
S131 2013-02-08 Real-time Process
S130 2013-01-03 Real-time Process
S129 2012-11-08 30-day Notice
S128 2012-10-15 30-day Notice
S127 2012-10-12 30-day Notice
S126 2012-10-02 30-day Notice
S125 2012-09-28 30-day Notice
S124 2012-09-25 30-day Notice
S123 2012-07-27 Real-time Process
S122 2012-07-26 Real-time Process
S121 2012-05-09 Real-time Process
S120 2012-03-26 30-day Notice
S119 2012-02-09 Normal 180 Day Track
S118 2012-01-24 30-day Notice
S117 2011-08-03 30-day Notice
S116 2011-05-25 30-day Notice
S115 2011-05-12 Real-time Process
S114
S113 2011-04-01 30-day Notice
S112 2011-03-31 30-day Notice
S111 2011-04-04 Real-time Process
S110 2011-01-24 Real-time Process
S109 2010-09-24 Real-time Process
S108 2010-08-23 Real-time Process
S107 2010-07-27 30-day Notice
S106 2010-07-15 30-day Notice
S105 2010-06-22 30-day Notice
S104 2010-03-24 Real-time Process
S103 2010-03-02 30-day Notice
S102 2010-02-05 Real-time Process
S101 2009-12-18 30-day Notice
S100 2009-12-16 30-day Notice
S099
S098 2009-10-16 30-day Notice
S097 2009-09-30 Real-time Process
S096 2009-06-17 135 Review Track For 30-day Notice
S095 2009-06-11 30-day Notice
S094 2009-05-26 Real-time Process
S093 2009-03-16 Real-time Process
S092 2009-03-04 Real-time Process
S091 2008-07-23 Real-time Process
S090 2008-07-22 Normal 180 Day Track
S089 2008-06-18 30-day Notice
S088 2008-06-03 30-day Notice
S087 2008-05-23 Real-time Process
S086 2008-04-11 30-day Notice
S085
S084 2008-02-28 Real-time Process
S083 2007-12-11 Real-time Process
S082
S081 2007-11-09 30-day Notice
S080 2007-10-11 30-day Notice
S079 2007-09-19 30-day Notice
S078 2007-09-07 Real-time Process
S077 2007-09-05 Normal 180 Day Track
S076 2007-08-23 Normal 180 Day Track
S075 2007-05-24 Normal 180 Day Track No User Fee
S074 2007-02-23 Real-time Process
S073 2007-02-22 Real-time Process
S072 2007-02-08 Special (immediate Track)
S071 2007-01-16 Real-time Process
S070
S069
S068 2007-01-11 Real-time Process
S067 2006-11-06 30-day Notice
S066 2006-11-01 Real-time Process
S065
S064
S063 2006-06-26 30-day Notice
S062 2006-05-25 Special (immediate Track)
S061 2006-04-18 Normal 180 Day Track
S060 2006-04-13 30-day Notice
S059 2006-04-13 30-day Notice
S058 2006-03-28 30-day Notice
S057 2005-12-15 Real-time Process
S056 2005-11-22 135 Review Track For 30-day Notice
S055 2005-10-31 Real-time Process
S054 2005-10-11 Real-time Process
S053 2005-10-11 135 Review Track For 30-day Notice
S052 2005-06-27 30-day Notice
S051 2005-03-15 Normal 180 Day Track
S050 2005-03-04 Normal 180 Day Track
S049 2004-12-03 30-day Notice
S048 2004-11-19 Real-time Process
S047 2004-10-21 30-day Notice
S046 2004-09-01 Normal 180 Day Track
S045 2004-04-14 30-day Notice
S044 2004-01-13 30-day Notice
S043 2003-11-26 Special (immediate Track)
S042 2003-11-20 30-day Notice
S041 2003-11-13 Normal 180 Day Track
S040 2003-07-16 Normal 180 Day Track
S039 2002-12-12 Normal 180 Day Track
S038 2002-11-13 30-day Notice
S037 2001-12-14 Panel Track
S036 2000-12-01 Real-time Process
S035 2000-11-07 Real-time Process
S034
S033 2000-08-21 Normal 180 Day Track
S032 2000-01-14 Real-time Process
S031 1999-12-20 Normal 180 Day Track
S030 1999-12-16 Normal 180 Day Track
S029 1999-10-06 Real-time Process
S028
S027 1999-02-17 Real-time Process
S026 1998-12-21 Real-time Process
S025 1998-09-10 Normal 180 Day Track
S024 1998-10-19 Real-time Process
S023 1998-06-24 Real-time Process
S022 1997-07-28 Normal 180 Day Track
S021 1997-07-18 Real-time Process
S020 1996-12-23 Normal 180 Day Track
S019 1996-10-16 Normal 180 Day Track
S018 1996-08-30 Normal 180 Day Track
S017
S016 1996-07-09 Normal 180 Day Track
S015 1996-05-10 Normal 180 Day Track
S014 1996-03-25 Normal 180 Day Track
S013
S012 1995-09-12 Normal 180 Day Track
S011 1995-08-25 Normal 180 Day Track
S010 1995-06-26 Normal 180 Day Track
S009 1995-06-14 Normal 180 Day Track
S008 1995-06-13 Normal 180 Day Track
S007 1995-04-06 Normal 180 Day Track
S006 1994-12-14 Normal 180 Day Track
S005
S004 1994-11-07 Normal 180 Day Track
S003
S002 1994-09-06 Normal 180 Day Track
S001 1994-08-05 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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00802526077494 P910077 000
00802526062568 P910077 000
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00802526557026 P910077 139
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00802526561603 P910077 140
00802526544224 P910077 140
00802526562105 P910077 143
00802526570322 P910077 143
00802526570209 P910077 143
00802526570322 P910077 143
00802526570209 P910077 143
00802526562105 P910077 143
00802526579707 P910077 144
00802526582004 P910077 144
00802526575303 P910077 144
00802526579707 P910077 144
00802526575303 P910077 144
00802526582004 P910077 144
00802526572722 P910077 147
00802526562914 P910077 147
00802526572722 P910077 147
00802526562914 P910077 147
00802526577451 P910077 149
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00802526585609 P910077 151
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00802526585807 P910077 159
00802526585821 P910077 159
00802526585838 P910077 159
00802526585005 P910077 159
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00802526585814 P910077 159
00802526585807 P910077 159
00802526585005 P910077 159
00802526585814 P910077 159
00802526610110 P910077 169

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