ENDOTAK RELIANCE AND ENDOTAK ENDURANCE

Implantable Cardioverter Defibrillator (non-crt)

FDA Premarket Approval P910073 S055

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 extend the shelf life of the drug plug component of the leads from one year to three years. The shelf life of the finished leads remains two years.

DeviceENDOTAK RELIANCE AND ENDOTAK ENDURANCE
Classification NameImplantable Cardioverter Defibrillator (non-crt)
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2005-10-06
Decision Date2005-11-15
PMAP910073
SupplementS055
Product CodeLWS
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P910073Original Filing
S171 2023-01-05 30-day Notice
S170 2022-11-01 30-day Notice
S169 2022-10-07 30-day Notice
S168 2022-02-23 30-day Notice
S167 2021-09-30 30-day Notice
S166 2021-09-30 30-day Notice
S165
S164 2021-09-23 30-day Notice
S163 2021-09-01 30-day Notice
S162 2021-05-25 30-day Notice
S161 2021-04-30 30-day Notice
S160 2021-03-08 30-day Notice
S159 2021-01-11 30-day Notice
S158 2020-10-08 Normal 180 Day Track No User Fee
S157 2020-04-16 Normal 180 Day Track No User Fee
S156 2019-05-21 30-day Notice
S155
S154 2019-03-13 30-day Notice
S153 2018-12-26 Real-time Process
S152 2018-12-20 30-day Notice
S151 2018-10-26 30-day Notice
S150 2018-07-13 30-day Notice
S149 2018-04-25 30-day Notice
S148 2018-03-26 30-day Notice
S147 2017-12-19 30-day Notice
S146 2017-12-19 Normal 180 Day Track
S145 2017-12-12 Normal 180 Day Track
S144 2017-11-20 30-day Notice
S143 2017-06-07 30-day Notice
S142 2017-05-26 Normal 180 Day Track
S141 2017-03-30 30-day Notice
S140 2016-12-14 30-day Notice
S139 2016-07-25 30-day Notice
S138 2016-07-18 Normal 180 Day Track
S137 2016-07-07 30-day Notice
S136 2016-06-27 30-day Notice
S135 2016-05-27 30-day Notice
S134 2016-04-06 30-day Notice
S133 2015-11-20 135 Review Track For 30-day Notice
S132 2015-08-07 Normal 180 Day Track
S131
S130 2015-06-22 30-day Notice
S129 2014-12-22 Normal 180 Day Track
S128 2014-09-03 Normal 180 Day Track
S127 2014-06-30 30-day Notice
S126 2014-06-09 30-day Notice
S125 2014-04-22 30-day Notice
S124 2014-02-21 Real-time Process
S123 2014-01-28 Real-time Process
S122 2013-12-23 Normal 180 Day Track
S121 2013-08-29 30-day Notice
S120 2013-08-19 30-day Notice
S119
S118 2013-05-28 Real-time Process
S117 2013-05-16 Real-time Process
S116 2013-03-19 Real-time Process
S115 2013-01-04 Real-time Process
S114 2012-11-21 30-day Notice
S113 2012-11-13 30-day Notice
S112 2012-11-08 30-day Notice
S111 2012-10-16 30-day Notice
S110 2012-10-09 30-day Notice
S109 2012-10-02 30-day Notice
S108 2012-10-05 30-day Notice
S107 2012-09-28 Normal 180 Day Track
S106 2012-09-04 30-day Notice
S105 2012-07-26 Real-time Process
S104 2012-06-19 30-day Notice
S103 2012-06-15 30-day Notice
S102 2012-05-14 Normal 180 Day Track No User Fee
S101 2012-03-26 30-day Notice
S100 2012-01-24 30-day Notice
S099 2011-10-21 30-day Notice
S098 2011-05-25 30-day Notice
S097 2011-05-04 30-day Notice
S096 2011-04-01 30-day Notice
S095 2011-04-01 30-day Notice
S094 2011-03-28 Real-time Process
S093 2011-03-01 30-day Notice
S092 2010-12-17 Real-time Process
S091 2010-12-14 Normal 180 Day Track
S090 2010-11-16 30-day Notice
S089 2010-10-29 135 Review Track For 30-day Notice
S088
S087
S086 2010-08-10 30-day Notice
S085 2010-07-14 30-day Notice
S084 2010-04-26 135 Review Track For 30-day Notice
S083 2010-04-23 30-day Notice
S082 2009-12-18 30-day Notice
S081 2009-12-16 30-day Notice
S080
S079 2009-08-24 30-day Notice
S078 2009-05-08 30-day Notice
S077 2009-02-24 Normal 180 Day Track
S076 2008-09-17 30-day Notice
S075 2008-09-12 Real-time Process
S074 2008-09-10 30-day Notice
S073 2008-05-02 135 Review Track For 30-day Notice
S072 2008-03-21 Real-time Process
S071
S070
S069
S068 2007-11-13 30-day Notice
S067 2007-07-16 30-day Notice
S066
S065 2006-04-13 30-day Notice
S064 2006-04-13 30-day Notice
S063
S062 2006-01-06 Real-time Process
S061 2005-12-02 30-day Notice
S060 2005-11-23 30-day Notice
S059 2005-11-09 30-day Notice
S058 2005-10-26 30-day Notice
S057 2005-10-24 30-day Notice
S056 2005-09-19 30-day Notice
S055 2005-10-06 Real-time Process
S054 2005-08-25 30-day Notice
S053 2005-08-01 30-day Notice
S052 2005-07-08 30-day Notice
S051 2005-06-15 30-day Notice
S050 2005-02-24 30-day Notice
S049 2004-12-03 30-day Notice
S048 2004-10-21 30-day Notice
S047 2004-08-17 30-day Notice
S046 2004-06-14 30-day Notice
S045 2004-04-14 30-day Notice
S044 2004-01-13 30-day Notice
S043 2003-12-04 Real-time Process
S042 2003-05-05 Real-time Process
S041 2003-03-04 Normal 180 Day Track
S040 2002-11-13 30-day Notice
S039 2002-03-11 Normal 180 Day Track
S038 2001-11-21 Real-time Process
S037 2000-12-01 Real-time Process
S036 2000-07-06 Normal 180 Day Track
S035 2000-09-13 Real-time Process
S034 2000-08-21 Normal 180 Day Track
S033 2000-07-12 Real-time Process
S032 2000-06-26 Real-time Process
S031 2000-01-14 Real-time Process
S030 2000-01-11 Real-time Process
S029 1999-12-16 Normal 180 Day Track
S028 2000-01-11 Real-time Process
S027 1999-07-26 Real-time Process
S026 1999-03-19 Normal 180 Day Track
S025 1998-07-30 Normal 180 Day Track
S024 1998-02-19 Normal 180 Day Track
S023 1997-10-16 Real-time Process
S022 1997-04-03 Normal 180 Day Track
S021 1996-10-16 Normal 180 Day Track
S020 1996-05-10 Normal 180 Day Track
S019 1995-10-02 Normal 180 Day Track
S018 1995-09-01 Normal 180 Day Track
S017 1995-05-19 Normal 180 Day Track
S016 1995-05-12 Normal 180 Day Track
S015 1995-05-01 Normal 180 Day Track
S014 1995-04-24 Normal 180 Day Track
S013 1995-03-30 Normal 180 Day Track
S012
S011 1995-01-30 Normal 180 Day Track
S010 1994-12-23 Normal 180 Day Track
S009
S008 1994-12-14 Normal 180 Day Track
S007 1994-11-23 Normal 180 Day Track
S006
S005 1994-08-22 Normal 180 Day Track
S004 1994-08-05 Normal 180 Day Track
S003 1994-07-01 Normal 180 Day Track
S002 1993-12-21 Normal 180 Day Track
S001 1993-12-01 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00802526489693 P910073 015
00802526489686 P910073 015
00802526489679 P910073 015
00802526068034 P910073 017
00802526067884 P910073 018
00802526489709 P910073 024
00802526489716 P910073 024
00802526489501 P910073 026
00802526489464 P910073 026
00802526489471 P910073 026
00802526489488 P910073 026
00802526489495 P910073 026
00802526489457 P910073 026
00802526491801 P910073 032
00802526489518 P910073 032
00802526489525 P910073 032
00802526066719 P910073 036
00802526373282 P910073 041
00802526373374 P910073 041
00802526376726 P910073 041
00802526373732 P910073 041
00802526373640 P910073 041
00802526376818 P910073 041
00802526085918 P910073 051
00802526085789 P910073 051
00802526085505 P910073 051
00802526474828 P910073 094
00802526474811 P910073 094
00802526474804 P910073 094
00802526431418 P910073 094
00802526431388 P910073 094
00802526431371 P910073 094
00802526431296 P910073 094
00802526431289 P910073 094
00802526431401 P910073 094
00802526531125 P910073 115
00802526531231 P910073 115
00802526531187 P910073 115
00802526531194 P910073 115
00802526531200 P910073 115
00802526531217 P910073 115
00802526531224 P910073 115
00802526531248 P910073 115
00802526531255 P910073 115
00802526531262 P910073 115
00802526531279 P910073 115
00802526531170 P910073 115
00802526531163 P910073 115
00802526531156 P910073 115
00802526531149 P910073 115
00802526531132 P910073 115
00802526531118 P910073 115
00802526531101 P910073 115
00802526527456 P910073 128
00802526601811 P910073 138
00802526601828 P910073 138
00802526601804 P910073 138
00802526601835 P910073 138
00802526592874 P910073 145
00802526592867 P910073 145
00802526592850 P910073 145
00802526592843 P910073 145
00802526592829 P910073 145
00802526592812 P910073 145
00802526592805 P910073 145
00802526496981 P910073 145
00802526497001 P910073 145
00802526497827 P910073 145
00802526592836 P910073 145
00802526496868 P910073 145
00802526496967 P910073 145

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