Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D

Implantable Pulse Generator, Pacemaker (non-crt)

FDA Premarket Approval N970003 S245

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

DeviceEssentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D
Classification NameImplantable Pulse Generator, Pacemaker (non-crt)
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantBoston Scientific Corp.
Date Received2019-11-22
Decision Date2019-11-27
PMAN970003
SupplementS245
Product CodeLWP
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 4100 Hamline Ave North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
N970003Original Filing
S245 2019-11-22 30-day Notice
S244 2019-10-21 30-day Notice
S243 2019-09-10 30-day Notice
S242
S241 2019-06-20 Real-time Process
S240 2019-05-31 30-day Notice
S239
S238 2019-03-20 Real-time Process
S237 2019-03-13 30-day Notice
S236
S235 2019-02-11 30-day Notice
S234
S233 2018-12-03 Real-time Process
S232 2018-10-19 30-day Notice
S231 2018-05-04 Real-time Process
S230
S229 2018-04-30 Normal 180 Day Track
S228 2018-03-26 30-day Notice
S227 2018-03-13 30-day Notice
S226 2018-02-16 30-day Notice
S225 2018-01-19 30-day Notice
S224 2018-01-18 Real-time Process
S223 2017-12-14 Real-time Process
S222 2017-11-21 30-day Notice
S221 2017-11-21 30-day Notice
S220 2017-11-20 30-day Notice
S219 2017-11-13 30-day Notice
S218 2017-11-02 30-day Notice
S217 2017-10-20 Real-time Process
S216 2017-09-29 30-day Notice
S215 2017-09-28 30-day Notice
S214 2017-09-27 30-day Notice
S213 2017-09-15 Real-time Process
S212 2017-09-05 30-day Notice
S211 2017-08-04 30-day Notice
S210 2017-08-02 30-day Notice
S209 2017-07-24 Real-time Process
S208 2017-07-17 Real-time Process
S207 2017-05-22 Real-time Process
S206 2017-04-07 30-day Notice
S205 2017-04-04 30-day Notice
S204 2017-04-03 Normal 180 Day Track
S203 2017-03-17 30-day Notice
S202 2017-03-15 30-day Notice
S201 2016-12-19 30-day Notice
S200 2016-11-22 Real-time Process
S199 2016-11-18 30-day Notice
S198 2016-11-03 30-day Notice
S197 2016-10-26 Normal 180 Day Track
S196 2016-10-03 30-day Notice
S195 2016-09-12 30-day Notice
S194 2016-09-02 30-day Notice
S193 2016-08-17 30-day Notice
S192 2016-07-15 30-day Notice
S191 2016-07-07 30-day Notice
S190 2016-05-26 30-day Notice
S189 2016-05-04 30-day Notice
S188 2016-04-27 30-day Notice
S187 2016-04-21 Real-time Process
S186 2016-02-17 Real-time Process
S185 2016-01-08 30-day Notice
S184 2015-12-21 Real-time Process
S183 0000-00-00
S182 2015-08-21 Real-time Process
S181 2015-07-17 30-day Notice
S180
S179 2015-06-26 30-day Notice
S178 2015-06-22 30-day Notice
S177 2015-06-18 30-day Notice
S176 2015-05-08 30-day Notice
S175 2015-04-27 Real-time Process
S174 2015-04-24 30-day Notice
S173 2015-04-23 30-day Notice
S172 2015-03-02 30-day Notice
S171 2015-02-23 30-day Notice
S170 2015-01-16 Real-time Process
S169 2014-11-20 Real-time Process
S168 2014-10-27 30-day Notice
S167 2014-07-25 Normal 180 Day Track
S166 2014-06-30 30-day Notice
S165 2014-06-09 30-day Notice
S164 2014-05-05 30-day Notice
S163 2014-05-02 30-day Notice
S162 2014-04-22 30-day Notice
S161 2014-04-14 30-day Notice
S160 2014-03-18 Real-time Process
S159 2014-02-21 Real-time Process
S158 2014-01-30 30-day Notice
S157 2013-10-29 30-day Notice
S156 2013-09-13 30-day Notice
S155 2013-08-29 30-day Notice
S154 2013-07-30 30-day Notice
S153 2013-06-03 30-day Notice
S152 2013-05-22 Real-time Process
S151 2013-05-08 30-day Notice
S150
S149
S148
S147
S146
S145
S144
S143 2012-10-25 Normal 180 Day Track
S142
S141
S140 2012-09-14
S139
S138
S137
S136
S135
S134
S133
S132
S131
S130
S129
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S001

NIH GUDID Devices

Device IDPMASupp
00802526489204 N970003 000
00802526489204 N970003 000
00802526516955 N970003 143
00802526516962 N970003 143
00802526517259 N970003 143
00802526536557 N970003 143
00802526516955 N970003 143
00802526536557 N970003 143
00802526516962 N970003 143
00802526517259 N970003 143
00802526536786 N970003 152
00802526516658 N970003 152
00802526516702 N970003 152
00802526516719 N970003 152
00802526516825 N970003 152
00802526516818 N970003 152
00802526516825 N970003 152
00802526536786 N970003 152
00802526516658 N970003 152
00802526516702 N970003 152
00802526516719 N970003 152
00802526516818 N970003 152
00802526484438 N970003 159
00802526484421 N970003 159
00802526484391 N970003 159
00802526484384 N970003 159
00802526499210 N970003 159
00802526499128 N970003 159
00802526484445 N970003 159
00802526484445 N970003 159
00802526484452 N970003 159
00802526484391 N970003 159
00802526484421 N970003 159
00802526484438 N970003 159
00802526484452 N970003 159
00802526484469 N970003 159
00802526484483 N970003 159
00802526484476 N970003 159
00802526484384 N970003 159
00802526484490 N970003 159
00802526499210 N970003 159
00802526499128 N970003 159
00802526484490 N970003 159
00802526484483 N970003 159
00802526484476 N970003 159
00802526484469 N970003 159
00802526559020 N970003 167
00802526558900 N970003 167
00802526558900 N970003 167
00802526558924 N970003 167
00802526558986 N970003 167
00802526559044 N970003 167
00802526559112 N970003 167
00802526559150 N970003 167
00802526559174 N970003 167
00802526559242 N970003 167
00802526559327 N970003 167
00802526559365 N970003 167
00802526559365 N970003 167
00802526559341 N970003 167
00802526558924 N970003 167
00802526558986 N970003 167
00802526559020 N970003 167
00802526559044 N970003 167
00802526559112 N970003 167
00802526559150 N970003 167
00802526559174 N970003 167
00802526559242 N970003 167
00802526559327 N970003 167
00802526559341 N970003 167

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