RELIANCE 4-FRONT

FDA Premarket Approval P910073 S157

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

DeviceRELIANCE 4-FRONT
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2020-04-16
Decision Date2020-07-07
PMAP910073
SupplementS157
Product CodeLWS 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product Yes
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P910073Original Filing
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
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