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.
To change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves
Device | PG ACCOLADE DR, PG ACCOLADE SR, PG ALTRUA 2 DR, PG ALTRUA 2 SR, PG ESSENTIO DR, PG ESSENTIO SR, PG PROPONENT DR, and PG |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | Boston Scientific Corp. |
Date Received | 2020-10-01 |
Decision Date | 2020-10-22 |
PMA | N970003 |
Supplement | S257 |
Product Code | LWP |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Boston Scientific Corp. 4100 Hamline Ave North st. Paul, MN 55112 |
Supplement Number | Date | Supplement Type |
---|---|---|
N970003 | Original Filing | |
S282 | 2022-12-12 | 30-day Notice |
S281 | 2022-12-07 | 30-day Notice |
S280 | 2022-10-26 | Real-time Process |
S279 | 2022-10-05 | 30-day Notice |
S278 | ||
S277 | ||
S276 | 2022-09-20 | 30-day Notice |
S275 | ||
S274 | 2022-07-21 | 30-day Notice |
S273 | 2022-06-29 | 30-day Notice |
S272 | 2021-12-16 | 30-day Notice |
S271 | 2021-12-07 | 30-day Notice |
S270 | ||
S269 | 2021-10-08 | 30-day Notice |
S268 | 2021-09-23 | 30-day Notice |
S267 | ||
S266 | 2021-06-21 | Real-time Process |
S265 | 2021-06-11 | Real-time Process |
S264 | 2021-04-30 | 30-day Notice |
S263 | 2021-04-28 | 30-day Notice |
S262 | 2021-04-26 | 30-day Notice |
S261 | 2021-03-08 | 30-day Notice |
S260 | 2020-12-08 | 30-day Notice |
S259 | ||
S258 | 2020-10-21 | 30-day Notice |
S257 | 2020-10-01 | 30-day Notice |
S256 | 2020-09-24 | 30-day Notice |
S255 | ||
S254 | ||
S253 | 2020-08-06 | 30-day Notice |
S252 | 2020-07-27 | 30-day Notice |
S251 | 2020-03-20 | Real-time Process |
S250 | 2020-03-13 | 30-day Notice |
S249 | 2020-03-02 | 30-day Notice |
S248 | 2020-01-27 | 30-day Notice |
S247 | ||
S246 | 2019-12-03 | 30-day Notice |
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 | 2015-11-04 | 30-day Notice |
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 | ||
S128 | ||
S127 | ||
S126 | ||
S125 | ||
S124 | ||
S123 | ||
S122 | ||
S121 | ||
S120 | ||
S119 | ||
S118 | ||
S117 | ||
S116 | ||
S115 | ||
S114 | ||
S113 | ||
S112 | ||
S111 | ||
S110 | ||
S109 | ||
S108 | ||
S107 | ||
S106 | ||
S105 | ||
S104 | ||
S103 | ||
S102 | ||
S101 | ||
S100 | ||
S099 | ||
S098 | ||
S097 | ||
S096 | ||
S095 | ||
S094 | ||
S093 | ||
S092 | ||
S091 | ||
S090 | ||
S089 | ||
S088 | ||
S087 | ||
S086 | ||
S085 | ||
S084 | ||
S083 | ||
S082 | ||
S081 | ||
S080 | ||
S079 | ||
S078 | ||
S077 | ||
S076 | ||
S075 | ||
S074 | ||
S073 | ||
S072 | ||
S071 | ||
S070 | ||
S069 | ||
S068 | ||
S067 | ||
S066 | ||
S065 | ||
S064 | ||
S063 | ||
S062 | ||
S061 | ||
S060 | ||
S059 | ||
S058 | ||
S057 | ||
S056 | ||
S055 | ||
S054 | ||
S053 | ||
S052 | ||
S051 | ||
S050 | ||
S049 | ||
S048 | ||
S047 | ||
S046 | ||
S045 | ||
S044 | ||
S043 | ||
S042 | ||
S041 | ||
S040 | ||
S039 | ||
S038 | ||
S037 | ||
S036 | ||
S035 | ||
S034 | ||
S033 | ||
S032 | ||
S031 | ||
S030 | ||
S029 | ||
S028 | ||
S027 | ||
S026 | ||
S025 | ||
S024 | ||
S023 | ||
S022 | ||
S021 | ||
S020 | ||
S019 | ||
S018 | ||
S017 | ||
S016 | ||
S015 | ||
S014 | ||
S013 | ||
S012 | ||
S011 | ||
S010 | ||
S009 | ||
S008 | ||
S007 | ||
S006 | ||
S005 | ||
S004 | ||
S003 | ||
S002 | ||
S001 |
Device ID | PMA | Supp |
---|---|---|
00802526489204 | N970003 | 000 |
00802526536557 | N970003 | 143 |
00802526517259 | N970003 | 143 |
00802526516962 | N970003 | 143 |
00802526516955 | N970003 | 143 |
00802526516818 | N970003 | 152 |
00802526516719 | N970003 | 152 |
00802526516702 | N970003 | 152 |
00802526536786 | N970003 | 152 |
00802526516658 | N970003 | 152 |
00802526516825 | N970003 | 152 |
00802526484490 | N970003 | 159 |
00802526484391 | N970003 | 159 |
00802526484421 | N970003 | 159 |
00802526484438 | N970003 | 159 |
00802526499210 | N970003 | 159 |
00802526484445 | N970003 | 159 |
00802526484452 | N970003 | 159 |
00802526484469 | N970003 | 159 |
00802526484476 | N970003 | 159 |
00802526484483 | N970003 | 159 |
00802526499128 | N970003 | 159 |
00802526484384 | N970003 | 159 |
00802526559341 | N970003 | 167 |
00802526559327 | N970003 | 167 |
00802526559242 | N970003 | 167 |
00802526559174 | N970003 | 167 |
00802526559150 | N970003 | 167 |
00802526559112 | N970003 | 167 |
00802526559044 | N970003 | 167 |
00802526559020 | N970003 | 167 |
00802526558986 | N970003 | 167 |
00802526558924 | N970003 | 167 |
00802526558900 | N970003 | 167 |
00802526559365 | N970003 | 167 |