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.
Approval for a site change from the bsc minnetonka, mn facility to the bsc st. Paul, minnesota facility.
Device | AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment |
Generic Name | Prosthesis, Penis, Inflatable |
Applicant | Boston Scientific Corp. |
Date Received | 2020-04-20 |
Decision Date | 2020-05-20 |
PMA | N970012 |
Supplement | S177 |
Product Code | JCW |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Boston Scientific Corp. 100 Boston Scientific Way marlborough, MA 01752 |
Supplement Number | Date | Supplement Type |
---|---|---|
N970012 | Original Filing | |
S194 | 2022-11-01 | 30-day Notice |
S193 | ||
S192 | 2022-08-19 | 30-day Notice |
S191 | 2022-03-22 | 30-day Notice |
S190 | 2022-03-15 | 30-day Notice |
S189 | 2021-08-24 | 30-day Notice |
S188 | 2021-06-11 | 30-day Notice |
S187 | 2021-04-30 | 30-day Notice |
S186 | ||
S185 | 2021-02-16 | 30-day Notice |
S184 | 2020-12-03 | 30-day Notice |
S183 | 2020-09-29 | 30-day Notice |
S182 | 2020-08-17 | 30-day Notice |
S181 | 2020-08-10 | 30-day Notice |
S180 | 2020-08-07 | 30-day Notice |
S179 | 2020-07-02 | 30-day Notice |
S178 | 2020-05-18 | 30-day Notice |
S177 | 2020-04-20 | Normal 180 Day Track No User Fee |
S176 | 2020-03-20 | 30-day Notice |
S175 | 2020-02-10 | 30-day Notice |
S174 | 2020-01-23 | 30-day Notice |
S173 | 2019-11-14 | 30-day Notice |
S172 | 2019-11-12 | 30-day Notice |
S171 | 2019-11-12 | 30-day Notice |
S170 | 2019-11-04 | 30-day Notice |
S169 | 2019-10-31 | 30-day Notice |
S168 | 2019-10-31 | 30-day Notice |
S167 | 2019-08-22 | 30-day Notice |
S166 | 2019-07-31 | 30-day Notice |
S165 | 2019-06-14 | 30-day Notice |
S164 | ||
S163 | ||
S162 | 2019-03-21 | 30-day Notice |
S161 | 2019-03-12 | Normal 180 Day Track No User Fee |
S160 | ||
S159 | 2019-02-25 | 30-day Notice |
S158 | ||
S157 | ||
S156 | 2019-01-18 | 30-day Notice |
S155 | 2019-01-16 | 30-day Notice |
S154 | ||
S153 | 2018-11-14 | 30-day Notice |
S152 | 2018-10-23 | 30-day Notice |
S151 | 2018-10-15 | Real-time Process |
S150 | 2018-09-28 | Real-time Process |
S149 | 2018-09-27 | 30-day Notice |
S148 | 2018-08-21 | 30-day Notice |
S147 | 2018-06-25 | 30-day Notice |
S146 | 2018-06-19 | 135 Review Track For 30-day Notice |
S145 | 2018-03-12 | Special (immediate Track) |
S144 | 2018-01-16 | 30-day Notice |
S143 | 2018-01-08 | 30-day Notice |
S142 | 2017-11-22 | 30-day Notice |
S141 | 2017-11-22 | 30-day Notice |
S140 | 2017-11-22 | 30-day Notice |
S139 | 2017-09-27 | Real-time Process |
S138 | 2017-09-08 | 30-day Notice |
S137 | 2017-07-17 | 30-day Notice |
S136 | 2017-06-29 | Real-time Process |
S135 | 2017-05-17 | Special (immediate Track) |
S134 | 2017-04-12 | 30-day Notice |
S133 | 2017-03-16 | 30-day Notice |
S132 | 2017-03-15 | 30-day Notice |
S131 | 2017-02-27 | Real-time Process |
S130 | 2017-02-21 | 30-day Notice |
S129 | 2017-02-06 | 135 Review Track For 30-day Notice |
S128 | 2017-01-30 | Real-time Process |
S127 | 2017-01-12 | 135 Review Track For 30-day Notice |
S126 | 2016-12-27 | 135 Review Track For 30-day Notice |
S125 | 2016-12-05 | 30-day Notice |
S124 | 2016-11-29 | 30-day Notice |
S123 | 2016-11-23 | 30-day Notice |
S122 | 2016-11-21 | 30-day Notice |
S121 | 2016-11-09 | Real-time Process |
S120 | 2016-11-04 | 30-day Notice |
S119 | 2016-09-29 | 135 Review Track For 30-day Notice |
S118 | 2016-09-19 | Real-time Process |
S117 | 2016-07-05 | 30-day Notice |
S116 | 2016-06-06 | 30-day Notice |
S115 | 2016-05-05 | 30-day Notice |
S114 | 2016-04-22 | 135 Review Track For 30-day Notice |
S113 | 2015-09-30 | Special (immediate Track) |
S112 | 2015-09-29 | 30-day Notice |
S111 | 2015-09-18 | 135 Review Track For 30-day Notice |
S110 | 2015-07-15 | Special (immediate Track) |
S109 | 2015-06-05 | 30-day Notice |
S108 | 2015-04-08 | 30-day Notice |
S107 | 2015-03-16 | 30-day Notice |
S106 | 2015-03-16 | 30-day Notice |
S105 | 2015-02-27 | 135 Review Track For 30-day Notice |
S104 | 2015-01-12 | 30-day Notice |
S103 | 2015-01-09 | Real-time Process |
S102 | 2014-11-03 | Real-time Process |
S101 | 2014-10-20 | 30-day Notice |
S100 | 2014-10-09 | 30-day Notice |
S099 | 2014-07-01 | 135 Review Track For 30-day Notice |
S098 | 2013-12-05 | 30-day Notice |
S097 | 2013-11-26 | 135 Review Track For 30-day Notice |
S096 | 2013-07-16 | Special (immediate Track) |
S095 | 2012-12-06 | 30-day Notice |
S094 | 2012-11-20 | Real-time Process |
S093 | 2012-09-10 | 30-day Notice |
S092 | 2012-07-03 | 30-day Notice |
S091 | ||
S090 | 2012-04-02 | 30-day Notice |
S089 | 2011-09-28 | 30-day Notice |
S088 | 2011-08-22 | 30-day Notice |
S087 | 2011-07-29 | 30-day Notice |
S086 | 2010-12-03 | 30-day Notice |
S085 | 2010-11-26 | 30-day Notice |
S084 | 2010-11-18 | Special (immediate Track) |
S083 | 2010-11-17 | Normal 180 Day Track |
S082 | 2010-11-17 | 30-day Notice |
S081 | 2010-11-12 | 30-day Notice |
S080 | ||
S079 | ||
S078 | 2010-07-27 | 30-day Notice |
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 |