Iforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia

FDA Premarket Approval P050023 S163

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 optimize the sterilization process parameters for p01 and p02 and propose a load change for p01

DeviceIforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia
Generic NameDefibrillator, Implantable, Dual-chamber
ApplicantBIOTRONIK, INC.
Date Received2021-09-30
Decision Date2021-10-29
PMAP050023
SupplementS163
Product CodeMRM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035

Supplemental Filings

Supplement NumberDateSupplement Type
P050023Original Filing
S163 2021-09-30 30-day Notice
S162
S161
S160 2021-07-21 30-day Notice
S159 2021-07-19 30-day Notice
S158 2021-06-21 30-day Notice
S157
S156 2021-05-05 30-day Notice
S155 2021-05-04 30-day Notice
S154 2021-03-16 Real-time Process
S153 2020-11-23 30-day Notice
S152 2020-11-02 30-day Notice
S151
S150 2020-08-10 Real-time Process
S149 2020-07-30 Normal 180 Day Track No User Fee
S148
S147 2020-04-30 Real-time Process
S146 2020-03-26 30-day Notice
S145
S144
S143 2020-02-11 30-day Notice
S142
S141 2019-12-31 30-day Notice
S140 2019-11-27 30-day Notice
S139
S138 2019-10-11 Real-time Process
S137
S136 2019-09-17 30-day Notice
S135 2019-08-19 30-day Notice
S134
S133 2019-07-01 Real-time Process
S132
S131 2019-04-23 30-day Notice
S130 2019-03-11 Real-time Process
S129 2019-01-23 30-day Notice
S128
S127 2018-11-16 30-day Notice
S126
S125 2018-09-12 Normal 180 Day Track
S124 2018-08-22 Real-time Process
S123 2018-07-13 Normal 180 Day Track
S122 2018-07-10 30-day Notice
S121 2018-06-14 135 Review Track For 30-day Notice
S120 2018-05-18 30-day Notice
S119 2018-05-17 Real-time Process
S118 2018-03-05 30-day Notice
S117 2018-02-23 135 Review Track For 30-day Notice
S116 2018-02-09 Normal 180 Day Track
S115 2018-01-22 30-day Notice
S114 2017-11-20 Real-time Process
S113 2017-10-18 Real-time Process
S112 2017-06-06 Real-time Process
S111 2017-05-24 Real-time Process
S110 2017-05-23 Normal 180 Day Track No User Fee
S109 2017-05-05 Real-time Process
S108 2017-04-20 Real-time Process
S107 2017-02-16 Normal 180 Day Track
S106 2017-01-03 30-day Notice
S105 2016-12-07 Normal 180 Day Track
S104 2016-08-08 Normal 180 Day Track
S103 2016-07-28 Normal 180 Day Track
S102 2016-06-09 Real-time Process
S101 2016-06-06 Normal 180 Day Track
S100 2016-06-02 Normal 180 Day Track No User Fee
S099 2016-05-31 30-day Notice
S098 2016-05-12 Real-time Process
S097 2016-03-24 Real-time Process
S096 2016-03-03 30-day Notice
S095 2016-01-21 Normal 180 Day Track No User Fee
S094 2015-12-23 Normal 180 Day Track
S093 2015-12-16 Real-time Process
S092 2015-05-27 30-day Notice
S091 2015-05-19 30-day Notice
S090 2015-05-11 Normal 180 Day Track
S089 2015-04-29 135 Review Track For 30-day Notice
S088 2015-04-16 30-day Notice
S087 2015-04-16 Normal 180 Day Track
S086 2015-03-27 Real-time Process
S085 2015-03-23 Normal 180 Day Track
S084 2015-03-06 135 Review Track For 30-day Notice
S083 2015-02-13 Real-time Process
S082 2014-10-31 30-day Notice
S081 2014-09-25 Normal 180 Day Track
S080 2014-09-24 30-day Notice
S079 2014-08-04 Normal 180 Day Track
S078 2014-07-31 Real-time Process
S077 2014-06-23 Normal 180 Day Track
S076 2014-01-27 Normal 180 Day Track
S075 2014-01-10 Real-time Process
S074 2013-11-25 Normal 180 Day Track
S073 2013-11-12 Real-time Process
S072 2013-11-07 Real-time Process
S071 2013-11-05 30-day Notice
S070 2013-11-05 30-day Notice
S069 2013-08-15 Real-time Process
S068 2013-07-16 30-day Notice
S067 2013-06-14 Real-time Process
S066 2013-06-03 Real-time Process
S065 2013-04-29 30-day Notice
S064 2013-04-22 30-day Notice
S063 2013-04-03 Real-time Process
S062
S061 2013-02-05 Real-time Process
S060 2013-01-14 30-day Notice
S059 2012-12-21 Real-time Process
S058 2012-12-18 Normal 180 Day Track
S057 2012-11-19 Real-time Process
S056 2012-10-12 Normal 180 Day Track No User Fee
S055 2012-09-07 30-day Notice
S054 2012-07-02 Real-time Process
S053 2012-03-01 Normal 180 Day Track
S052 2012-02-17 Real-time Process
S051 2012-02-06 30-day Notice
S050 2012-02-01 Real-time Process
S049 2012-01-30 Real-time Process
S048 2011-11-02 Normal 180 Day Track
S047 2011-08-22 Normal 180 Day Track
S046 2011-08-19 Normal 180 Day Track
S045 2011-04-11 Real-time Process
S044 2011-03-23 30-day Notice
S043 2010-12-23 30-day Notice
S042
S041 2010-12-13 Real-time Process
S040 2010-11-09 30-day Notice
S039 2010-10-28 Normal 180 Day Track
S038 2010-09-30 Real-time Process
S037 2010-08-20 30-day Notice
S036 2010-07-21 30-day Notice
S035 2010-05-18 Normal 180 Day Track No User Fee
S034 2010-06-29 Real-time Process
S033 2010-06-08 Normal 180 Day Track
S032 2010-05-28 Normal 180 Day Track No User Fee
S031 2010-05-11 Real-time Process
S030 2010-04-13 30-day Notice
S029 2010-03-02 Real-time Process
S028 2009-11-25 Real-time Process
S027 2009-09-28 135 Review Track For 30-day Notice
S026 2009-09-10 Real-time Process
S025
S024 2009-07-08 Normal 180 Day Track
S023 2009-03-23 Real-time Process
S022 2009-03-06 30-day Notice
S021 2009-02-13 Real-time Process
S020 2009-01-26 Normal 180 Day Track
S019 2008-11-17 Normal 180 Day Track
S018 2008-10-31 Real-time Process
S017 2008-09-25 135 Review Track For 30-day Notice
S016 2008-09-10 Normal 180 Day Track
S015 2008-07-03 135 Review Track For 30-day Notice
S014 2008-06-04 135 Review Track For 30-day Notice
S013 2008-05-21 Real-time Process
S012 2008-05-14 Real-time Process
S011 2008-05-14 Normal 180 Day Track
S010 2008-01-24 Real-time Process
S009 2008-01-15 Real-time Process
S008 2007-10-26 Normal 180 Day Track
S007 2007-08-13 Normal 180 Day Track
S006 2007-07-13 Normal 180 Day Track
S005 2007-06-25 30-day Notice
S004
S003 2007-01-22 Real-time Process
S002 2006-10-03 Normal 180 Day Track No User Fee
S001 2006-09-11 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04035479110024 P050023 087
04035479110017 P050023 087

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