Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)

FDA Premarket Approval P030005 S191

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 replace the current automated optical inspection equipment system and to update the inspection process

DeviceValitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL
Classification NamePulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
Generic NamePulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
ApplicantGUIDANT CORP.
Date Received2019-11-22
Decision Date2019-11-27
PMAP030005
SupplementS191
Product CodeNKE
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address GUIDANT CORP. 4100 Hamline Avenue North st. Paul, MN 55112-5798

Supplemental Filings

Supplement NumberDateSupplement Type
P030005Original Filing
S191 2019-11-22 30-day Notice
S190 2019-10-21 30-day Notice
S189 2019-09-10 30-day Notice
S188
S187 2019-07-12 30-day Notice
S186
S185 2019-05-31 30-day Notice
S184 2019-04-10 Real-time Process
S183 2019-03-20 Real-time Process
S182
S181 2019-02-11 30-day Notice
S180
S179 2018-12-03 Real-time Process
S178 2018-10-19 30-day Notice
S177
S176 2018-04-30 Normal 180 Day Track
S175 2018-03-26 30-day Notice
S174 2018-02-16 30-day Notice
S173 2018-01-19 30-day Notice
S172 2018-01-18 Real-time Process
S171 2017-12-14 Real-time Process
S170 2017-11-21 30-day Notice
S169 2017-11-21 30-day Notice
S168 2017-11-20 30-day Notice
S167 2017-11-13 30-day Notice
S166 2017-11-02 30-day Notice
S165 2017-10-20 Real-time Process
S164 2017-09-29 30-day Notice
S163 2017-09-28 30-day Notice
S162 2017-09-27 30-day Notice
S161 2017-09-15 Real-time Process
S160 2017-09-05 30-day Notice
S159 2017-08-04 30-day Notice
S158 2017-08-02 30-day Notice
S157 2017-07-24 Real-time Process
S156 2017-07-17 Real-time Process
S155 2017-05-22 Real-time Process
S154 2017-04-07 30-day Notice
S153 2017-04-04 30-day Notice
S152 2017-04-03 Normal 180 Day Track
S151 2017-03-17 30-day Notice
S150 2017-01-30 30-day Notice
S149 2016-12-19 30-day Notice
S148 2016-11-22 Real-time Process
S147 2016-11-18 30-day Notice
S146 2016-11-03 30-day Notice
S145 2016-10-26 Normal 180 Day Track
S144 2016-10-03 30-day Notice
S143 2016-09-12 30-day Notice
S142 2016-09-02 30-day Notice
S141 2016-08-17 30-day Notice
S140 2016-07-15 30-day Notice
S139 2016-07-07 30-day Notice
S138 2016-07-05 Normal 180 Day Track
S137 2016-05-26 30-day Notice
S136 2016-05-04 30-day Notice
S135 2016-04-27 30-day Notice
S134 2016-04-21 Real-time Process
S133 2016-02-17 Real-time Process
S132 2016-01-08 30-day Notice
S131 2015-12-21 Real-time Process
S130 2015-11-04 30-day Notice
S129 2015-08-21 Real-time Process
S128 2015-07-17 30-day Notice
S127
S126 2015-06-26 30-day Notice
S125 2015-06-22 30-day Notice
S124 2015-06-18 30-day Notice
S123 2015-05-08 30-day Notice
S122 2015-04-27 Real-time Process
S121 2015-04-24 30-day Notice
S120 2015-04-23 30-day Notice
S119 2015-03-18 Real-time Process
S118 2015-03-02 30-day Notice
S117 2015-02-23 30-day Notice
S116 2015-01-16 Real-time Process
S115 2014-11-20 Real-time Process
S114 2014-10-27 30-day Notice
S113 2014-07-25 Normal 180 Day Track
S112 2014-06-30 30-day Notice
S111 2014-06-09 30-day Notice
S110 2014-05-05 30-day Notice
S109 2014-05-02 30-day Notice
S108 2014-04-14 30-day Notice
S107 2014-03-18 Real-time Process
S106 2014-02-21 Real-time Process
S105 2014-01-30 30-day Notice
S104 2013-10-29 30-day Notice
S103 2013-09-13 30-day Notice
S102 2013-08-29 30-day Notice
S101 2013-07-30 30-day Notice
S100 2013-06-03 30-day Notice
S099 2013-05-22 Real-time Process
S098 2013-05-08 30-day Notice
S097 2013-03-29 30-day Notice
S096 2012-12-21 30-day Notice
S095
S094 2012-12-12 30-day Notice
S093 2012-11-08 30-day Notice
S092 2012-10-25 Normal 180 Day Track
S091
S090 2012-10-10 30-day Notice
S089 2012-10-01 30-day Notice
S088 2012-09-14 Normal 180 Day Track
S087 2012-09-11 30-day Notice
S086 2012-07-06 Real-time Process
S085 2012-07-06 135 Review Track For 30-day Notice
S084 2012-05-31 30-day Notice
S083 2012-04-27 30-day Notice
S082 2012-03-26 30-day Notice
S081 2012-01-30 Real-time Process
S080 2011-11-21 30-day Notice
S079 2011-07-12 Normal 180 Day Track
S078 2011-06-03 30-day Notice
S077 2011-05-25 30-day Notice
S076 2011-05-06 30-day Notice
S075 2011-04-06 30-day Notice
S074 2011-04-01 30-day Notice
S073 2011-03-18 Real-time Process
S072 2010-12-20 30-day Notice
S071 2010-09-01 30-day Notice
S070 2010-08-23 Real-time Process
S069 2010-08-18 30-day Notice
S068 2010-08-06 30-day Notice
S067
S066
S065 2010-07-15 30-day Notice
S064 2010-04-20 30-day Notice
S063 2010-04-16 30-day Notice
S062 2010-03-08 30-day Notice
S061 2010-02-04 30-day Notice
S060 2009-12-16 30-day Notice
S059 2009-11-19 30-day Notice
S058 2009-05-22 135 Review Track For 30-day Notice
S057 2009-04-21 30-day Notice
S056 2009-02-09 30-day Notice
S055 2008-11-26 Real-time Process
S054 2008-08-29 30-day Notice
S053 2008-06-18 30-day Notice
S052 2008-06-03 30-day Notice
S051 2008-03-03 30-day Notice
S050 2008-02-14 Real-time Process
S049 2007-12-21 30-day Notice
S048 2007-11-09 30-day Notice
S047 2007-09-26 30-day Notice
S046 2007-08-23 Normal 180 Day Track
S045
S044 2007-07-13 30-day Notice
S043 2007-03-14 30-day Notice
S042 2007-02-28 30-day Notice
S041 2007-01-17 30-day Notice
S040 2006-11-06 30-day Notice
S039 2006-11-01 Real-time Process
S038
S037 2006-06-26 30-day Notice
S036
S035 2006-05-12 Normal 180 Day Track
S034 2006-04-13 30-day Notice
S033 2006-03-28 30-day Notice
S032 2006-03-03 30-day Notice
S031 2006-03-03 30-day Notice
S030 2006-03-01 30-day Notice
S029 2005-12-21 135 Review Track For 30-day Notice
S028 2005-12-21 30-day Notice
S027 2005-12-05 Real-time Process
S026
S025
S024 2005-11-16 30-day Notice
S023 2005-11-03 30-day Notice
S022 2005-10-11 135 Review Track For 30-day Notice
S021 2005-10-03 135 Review Track For 30-day Notice
S020 2005-09-09 30-day Notice
S019 2005-08-29 135 Review Track For 30-day Notice
S018 2005-08-25 30-day Notice
S017
S016 2005-08-15 30-day Notice
S015 2005-08-15 30-day Notice
S014 2005-08-15 30-day Notice
S013 2005-08-12 30-day Notice
S012 2005-08-12 30-day Notice
S011 2005-08-11 30-day Notice
S010 2005-06-27 30-day Notice
S009 2005-06-21 30-day Notice
S008 2005-03-18 Real-time Process
S007
S006 2004-12-03 30-day Notice
S005 2004-11-22 Normal 180 Day Track
S004 2004-10-21 30-day Notice
S003 2004-06-21 Real-time Process
S002 2004-06-08 Special (immediate Track)
S001 2004-02-04 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00802526536663 P030005 092
00802526536670 P030005 092
00802526536663 P030005 092
00802526536670 P030005 092
00802526536625 P030005 099
00802526536632 P030005 099
00802526536625 P030005 099
00802526536632 P030005 099
00802526559389 P030005 113
00802526559402 P030005 113
00802526559389 P030005 113
00802526559402 P030005 113
00802526559426 P030005 138
00802526559457 P030005 138
00802526559471 P030005 138
00802526559426 P030005 138
00802526559457 P030005 138
00802526559471 P030005 138

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