Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Transvene CS/SVC Lead

FDA Premarket Approval P920015 S242

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 transfer two incoming inspection activities for device components from medtronic rice creek to medtronic puerto rico operations company villalba/juncos sites

DeviceY Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Transvene CS/SVC Lead
Generic NamePermanent Defibrillator Electrodes
ApplicantMEDTRONIC Inc.
Date Received2020-02-20
Decision Date2020-03-06
PMAP920015
SupplementS242
Product CodeNVY 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P920015Original Filing
S242 2020-02-20 30-day Notice
S241 2020-01-27 30-day Notice
S240 2019-12-17 30-day Notice
S239 2019-11-18 30-day Notice
S238 2019-11-13 30-day Notice
S237 2019-11-12 30-day Notice
S236 2019-09-16 30-day Notice
S235 2019-07-01 30-day Notice
S234
S233 2019-06-20 30-day Notice
S232 2019-06-10 30-day Notice
S231 2019-05-31 30-day Notice
S230 2019-05-20 30-day Notice
S229 2019-05-02 Normal 180 Day Track No User Fee
S228 2019-04-05 30-day Notice
S227 2019-03-04 30-day Notice
S226 2019-02-28 30-day Notice
S225 2019-01-30 Normal 180 Day Track No User Fee
S224 2018-11-21 30-day Notice
S223 2018-11-02 30-day Notice
S222
S221 2018-10-23 30-day Notice
S220 2018-10-18 30-day Notice
S219 2018-10-11 30-day Notice
S218 2018-09-26 30-day Notice
S217 2018-06-25 Real-time Process
S216 2018-06-20 30-day Notice
S215 2018-06-01 30-day Notice
S214 2018-05-15 30-day Notice
S213 2018-04-13 Normal 180 Day Track
S212 2018-04-09 30-day Notice
S211 2018-04-06 30-day Notice
S210 2018-03-28 30-day Notice
S209 2018-02-26 30-day Notice
S208 2018-02-22 30-day Notice
S207 2018-02-22 30-day Notice
S206 2018-02-12 Real-time Process
S205 2017-12-21 30-day Notice
S204 2017-12-04 Real-time Process
S203 2017-11-20 30-day Notice
S202 2017-08-09 30-day Notice
S201 2017-08-07 30-day Notice
S200 2017-06-28 30-day Notice
S199 2017-06-23 30-day Notice
S198 2017-06-07 30-day Notice
S197 2017-05-12 30-day Notice
S196 2017-01-25 Real-time Process
S195 2017-01-17 30-day Notice
S194 2017-01-06 30-day Notice
S193 2016-12-23 30-day Notice
S192 2016-12-22 30-day Notice
S191 2016-12-06 Normal 180 Day Track
S190 2016-11-28 30-day Notice
S189 2016-11-14 30-day Notice
S188 2016-11-02 Normal 180 Day Track
S187 2016-10-25 30-day Notice
S186 2016-10-05 30-day Notice
S185 2016-09-22 30-day Notice
S184 2016-09-12 30-day Notice
S183 2016-09-02 30-day Notice
S182 2016-08-25 30-day Notice
S181 2016-06-24 30-day Notice
S180 2016-05-27 30-day Notice
S179 2016-05-03 Normal 180 Day Track
S178 2016-04-15 Normal 180 Day Track
S177 2016-03-11 Normal 180 Day Track
S176 2016-03-08 30-day Notice
S175 2016-03-01 Normal 180 Day Track
S174 2016-02-17 30-day Notice
S173 2016-01-14 30-day Notice
S172 2016-01-11 30-day Notice
S171 2016-01-07 30-day Notice
S170 2015-12-28 30-day Notice
S169 2015-12-22 30-day Notice
S168 2015-10-30 Real-time Process
S167 2015-10-23 30-day Notice
S166 2015-10-13 Normal 180 Day Track
S165 2015-09-30 30-day Notice
S164 2015-09-30 Normal 180 Day Track
S163 2015-09-24 Normal 180 Day Track
S162 2015-09-10 30-day Notice
S161 2015-07-14 30-day Notice
S160 2015-07-06 30-day Notice
S159 2015-07-02 Real-time Process
S158 2015-06-25 30-day Notice
S157 2015-06-18 30-day Notice
S156 2015-06-08 30-day Notice
S155 2015-05-28 Normal 180 Day Track
S154
S153 2015-04-17 30-day Notice
S152 2015-04-14 Real-time Process
S151 2015-03-16 Normal 180 Day Track
S150 2015-03-12 30-day Notice
S149 2015-02-09 30-day Notice
S148 2015-02-09 30-day Notice
S147 2015-01-21 30-day Notice
S146 2014-12-22 Normal 180 Day Track
S145 2014-10-15 30-day Notice
S144 2014-09-29 30-day Notice
S143 2014-09-15 30-day Notice
S142 2014-09-15 30-day Notice
S141 2014-09-05 30-day Notice
S140 2014-08-27 30-day Notice
S139 2014-08-13 30-day Notice
S138 2014-08-08 30-day Notice
S137 2014-07-28 30-day Notice
S136 2014-07-24 30-day Notice
S135 2014-07-14 30-day Notice
S134 2014-07-09 30-day Notice
S133 2014-07-02 Real-time Process
S132 2014-06-16 30-day Notice
S131 2014-02-27 30-day Notice
S130
S129 2014-01-29 30-day Notice
S128 2013-12-24 30-day Notice
S127 2013-12-19 30-day Notice
S126 2013-12-17 30-day Notice
S125 2013-11-27 30-day Notice
S124 2013-11-22 30-day Notice
S123 2013-10-30 30-day Notice
S122 2013-10-24 Real-time Process
S121 2013-10-24 30-day Notice
S120 2013-09-30 30-day Notice
S119 2013-09-30 30-day Notice
S118 2013-09-17 30-day Notice
S117 2013-09-13 Normal 180 Day Track No User Fee
S116 2013-09-13 30-day Notice
S115
S114 2013-07-26 30-day Notice
S113 2013-05-17 Real-time Process
S112
S111 2013-04-30 30-day Notice
S110
S109 2013-04-10 Normal 180 Day Track No User Fee
S108 2013-04-08 135 Review Track For 30-day Notice
S107 2013-03-22 30-day Notice
S106 2013-03-21 30-day Notice
S105 2013-03-20 30-day Notice
S104 2012-12-21 30-day Notice
S103 2012-12-18 30-day Notice
S102 2012-12-10 30-day Notice
S101 2012-11-29 30-day Notice
S100 2012-11-21 30-day Notice
S099 2012-10-31 Real-time Process
S098 2012-10-26 Real-time Process
S097 2012-09-28 30-day Notice
S096 2012-09-21 30-day Notice
S095 2012-09-04 30-day Notice
S094 2012-08-03 30-day Notice
S093 2012-07-02 Normal 180 Day Track
S092 2012-06-11 30-day Notice
S091 2012-05-23 Real-time Process
S090 2012-03-26 Real-time Process
S089 2012-03-07 30-day Notice
S088 2012-02-29 30-day Notice
S087 2012-02-27 30-day Notice
S086 2012-02-23 30-day Notice
S085 2011-11-25 30-day Notice
S084 2011-11-21 Normal 180 Day Track
S083 2011-10-24 135 Review Track For 30-day Notice
S082 2011-07-18 30-day Notice
S081 2011-07-08 30-day Notice
S080 2011-06-28 30-day Notice
S079 2011-06-08 30-day Notice
S078 2011-06-08 135 Review Track For 30-day Notice
S077 2011-05-13 30-day Notice
S076 2011-04-26 30-day Notice
S075 2011-04-12 30-day Notice
S074 2011-03-22 135 Review Track For 30-day Notice
S073 2011-02-28 30-day Notice
S072 2010-12-10 30-day Notice
S071 2010-11-12 30-day Notice
S070 2010-10-26 30-day Notice
S069 2010-10-22 Special (immediate Track)
S068 2010-10-14 30-day Notice
S067 2010-09-29 30-day Notice
S066
S065 2010-07-15 30-day Notice
S064 2010-07-15 30-day Notice
S063 2010-07-15 30-day Notice
S062 2010-07-06 30-day Notice
S061 2010-06-28 135 Review Track For 30-day Notice
S060
S059 2010-03-29 30-day Notice
S058 2010-01-19 30-day Notice
S057 2010-01-15 Real-time Process
S056 2009-12-16 Normal 180 Day Track No User Fee
S055 2009-12-04 Normal 180 Day Track
S054 2009-03-26 Normal 180 Day Track No User Fee
S053 2009-03-17 Real-time Process
S052 2009-02-05 30-day Notice
S051 2008-12-11 30-day Notice
S050 2008-11-03 30-day Notice
S049 2008-10-27 30-day Notice
S048
S047 2008-07-09 30-day Notice
S046 2008-06-17 30-day Notice
S045 2008-06-13 135 Review Track For 30-day Notice
S044 2008-04-14 30-day Notice
S043 2008-04-01 30-day Notice
S042 2008-03-31 30-day Notice
S041 2008-03-24 30-day Notice
S040 2008-03-10 135 Review Track For 30-day Notice
S039 2008-03-03 Real-time Process
S038 2007-09-12 135 Review Track For 30-day Notice
S037 2007-05-15 Real-time Process
S036 2006-11-20 30-day Notice
S035 2006-05-10 135 Review Track For 30-day Notice
S034
S033
S032 2005-09-02 135 Review Track For 30-day Notice
S031 2004-09-10 Normal 180 Day Track
S030 2003-12-22 Normal 180 Day Track
S029 2003-11-06 Normal 180 Day Track
S028 2003-04-28 Real-time Process
S027 2003-03-04 30-day Notice
S026
S025 2001-11-05 Special (immediate Track)
S024 2001-10-01 Real-time Process
S023 2001-07-17 30-day Notice
S022 2001-05-31 Real-time Process
S021 2001-02-05 Normal 180 Day Track
S020 2000-11-13 Real-time Process
S019
S018
S017 2000-06-20 Normal 180 Day Track
S016 1999-08-12 Special (immediate Track)
S015 1998-09-28 Normal 180 Day Track
S014 1998-04-20
S013 1997-07-21 Normal 180 Day Track
S012 1997-03-18 Normal 180 Day Track
S011 1996-05-20 Normal 180 Day Track
S010 1996-05-17 Normal 180 Day Track
S009 1996-02-05 Normal 180 Day Track
S008 1995-08-10 Normal 180 Day Track
S007 1995-08-07 Normal 180 Day Track
S006 1995-07-18 Normal 180 Day Track
S005 1995-06-29 Normal 180 Day Track
S004 1995-01-20 Normal 180 Day Track
S003 1994-04-25 Normal 180 Day Track
S002 1994-03-25 Normal 180 Day Track
S001 1994-03-03 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00613994618177 P920015 001
00613994618177 P920015 001
00681490148450 P920015 009
00681490148405 P920015 009
00613994793942 P920015 009
00681490148405 P920015 009
00681490148450 P920015 009
00613994793942 P920015 009
00613994249951 P920015 017
00613994249975 P920015 017
00613994249975 P920015 017
00613994249951 P920015 017
00681490743761 P920015 021
00681490743761 P920015 021
00721902183065 P920015 021
00721902183072 P920015 021
00721902183072 P920015 021
00721902183065 P920015 021
00721902066825 P920015 022
00721902066801 P920015 022
00721902066825 P920015 022
00721902066801 P920015 022
00613994250094 P920015 024
00613994740939 P920015 024
00613994249890 P920015 024
00613994740922 P920015 024
00613994740908 P920015 024
00613994249876 P920015 024
00613994249876 P920015 024
00613994249890 P920015 024
00613994740908 P920015 024
00613994740922 P920015 024
00613994740915 P920015 024
00613994250094 P920015 024
00613994740915 P920015 024
00613994740939 P920015 024
00613994446350 P920015 039
00613994446367 P920015 039
00613994446374 P920015 039
00613994446343 P920015 039
00613994446336 P920015 039
00613994446121 P920015 039
00613994446114 P920015 039
00613994446084 P920015 039
00613994446114 P920015 039
00613994446107 P920015 039
00613994446091 P920015 039
00613994446336 P920015 039
00613994446343 P920015 039
00613994446107 P920015 039
00613994446350 P920015 039
00613994446367 P920015 039
00613994446091 P920015 039
00613994446084 P920015 039
00613994446121 P920015 039
00613994446374 P920015 039
00613994501035 P920015 054
00613994501035 P920015 054
00643169082304 P920015 055
00643169082281 P920015 055
00643169082281 P920015 055
00643169082243 P920015 055
00643169082267 P920015 055
00643169082229 P920015 055
00643169082229 P920015 055
00643169082243 P920015 055
00643169082267 P920015 055
00643169082304 P920015 055
00613994568014 P920015 056
00613994568021 P920015 056
00613994568021 P920015 056
00613994568014 P920015 056
00613994718839 P920015 091
00613994718853 P920015 091
00613994718877 P920015 091
00613994718891 P920015 091
00613994718891 P920015 091
00613994808004 P920015 091
00613994808004 P920015 091
00613994718877 P920015 091
00613994718839 P920015 091
00613994718853 P920015 091
00613994220288 P920015 093
00613994220288 P920015 093
00643169309708 P920015 099
00643169309739 P920015 099
00643169309791 P920015 099
00643169309784 P920015 099
00643169309708 P920015 099
00643169309777 P920015 099
00643169309760 P920015 099
00643169309753 P920015 099
00643169309715 P920015 099
00643169309791 P920015 099
00643169309784 P920015 099
00643169309715 P920015 099
00643169309722 P920015 099
00643169309739 P920015 099
00643169309746 P920015 099
00643169309753 P920015 099
00643169309760 P920015 099
00643169309777 P920015 099
00643169309746 P920015 099
00643169309722 P920015 099
00763000059385 P920015 113
00763000059385 P920015 113
00643169451452 P920015 138
00643169535909 P920015 138
00643169535893 P920015 138
00643169451476 P920015 138
00643169451469 P920015 138
00643169440852 P920015 138
00643169535947 P920015 138
00643169535916 P920015 138
00643169535923 P920015 138
00643169535930 P920015 138
00643169550964 P920015 138
00643169550957 P920015 138
00643169550940 P920015 138
00643169550933 P920015 138
00643169550926 P920015 138
00643169550919 P920015 138
00643169550902 P920015 138
00643169550896 P920015 138
00643169550889 P920015 138
00643169541184 P920015 138
00643169541177 P920015 138
00643169535978 P920015 138
00643169535961 P920015 138
00643169535954 P920015 138
00643169550889 P920015 138
00643169535947 P920015 138
00643169550971 P920015 138
00643169535909 P920015 138
00643169535916 P920015 138
00643169535923 P920015 138
00643169535930 P920015 138
00643169550926 P920015 138
00643169550919 P920015 138
00643169535954 P920015 138
00643169535961 P920015 138
00643169535978 P920015 138
00643169541177 P920015 138
00643169541184 P920015 138
00643169550933 P920015 138
00643169550940 P920015 138
00643169535893 P920015 138
00643169550971 P920015 138
00643169550964 P920015 138
00643169550957 P920015 138
00643169550902 P920015 138
00643169440852 P920015 138
00643169451452 P920015 138
00643169451469 P920015 138
00643169451476 P920015 138
00643169550896 P920015 138
00643169356566 P920015 151
00643169356559 P920015 151
00643169356610 P920015 151
00643169356627 P920015 151
00643169356566 P920015 151
00643169356610 P920015 151
00643169356559 P920015 151
00643169356627 P920015 151
00643169335592 P920015 155
00643169335585 P920015 155
00643169335592 P920015 155
00643169335561 P920015 155
00643169335578 P920015 155
00643169335561 P920015 155
00643169335585 P920015 155
00643169335578 P920015 155
00643169300842 P920015 168
00643169300842 P920015 168
00643169692374 P920015 178
00643169690035 P920015 178
00643169692381 P920015 178
00643169690042 P920015 178
00643169692381 P920015 178
00643169692374 P920015 178
00643169690042 P920015 178
00643169690035 P920015 178
00643169858305 P920015 196
00643169858305 P920015 196
00643169858329 P920015 196
00643169858329 P920015 196

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.