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.
Requested a sterilization site change for approval of bsc coventry, rhode island as an additional sterilization site for ethylene oxide (eo) cycle 101 due to the closure of the sterigenics willowbrook facility.
| Device | AMS Ambicor Inflatable Penile Prosthesis |
| Classification Name | Prosthesis, Penis, Inflatable |
| Generic Name | Prosthesis, Penis, Inflatable |
| Applicant | Boston Scientific Corp. |
| Date Received | 2019-03-12 |
| Decision Date | 2019-03-28 |
| PMA | N970012 |
| Supplement | S161 |
| 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 | Yes |
| 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 | ||
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| S070 | ||
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| S002 | ||
| S001 |