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.
| Device | AMS 800 Artificial Urinary Sphincter with InhibiZone™ |
| Generic Name | Device, Incontinence, Mechanical/hydraulic |
| Applicant | Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberP000053 Supplement NumberS123 Date Received03/01/2022 Decision Date03/07/2022 Product Code EZY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-03-07 |
| PMA | P000053 |
| Supplement | S123 |
| Product Code | EZY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 100 Boston Scientific Way marlborough, MA 01752 PMA NumberP000053 Supplement NumberS123 Date Received03/01/2022 Decision Date03/07/2022 Product Code EZY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement adding Alternate Tubing For The Manual Control Pump Test Fixture |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000053 | Original Filing | |
| S128 | 2022-11-01 | 30-day Notice |
| S127 | 2022-08-19 | 30-day Notice |
| S126 | 2022-06-23 | 30-day Notice |
| S125 | 2022-03-22 | 30-day Notice |
| S124 | 2022-03-15 | 30-day Notice |
| S123 | 2022-03-01 | 30-day Notice |
| S122 | ||
| S121 | 2021-06-11 | 30-day Notice |
| S120 | 2021-04-30 | 30-day Notice |
| S119 | 2020-12-03 | 30-day Notice |
| S118 | 2020-11-13 | 30-day Notice |
| S117 | 2020-09-29 | 30-day Notice |
| S116 | 2020-08-17 | 30-day Notice |
| S115 | 2020-08-07 | 30-day Notice |
| S114 | 2020-07-02 | 30-day Notice |
| S113 | 2020-05-18 | 30-day Notice |
| S112 | 2020-04-20 | Normal 180 Day Track No User Fee |
| S111 | 2020-02-10 | 30-day Notice |
| S110 | 2019-11-12 | 30-day Notice |
| S109 | 2019-11-04 | 30-day Notice |
| S108 | 2019-10-31 | 30-day Notice |
| S107 | 2019-08-22 | 30-day Notice |
| S106 | 2019-07-31 | 30-day Notice |
| S105 | ||
| S104 | ||
| S103 | 2019-03-12 | Normal 180 Day Track No User Fee |
| S102 | 2019-03-01 | 30-day Notice |
| S101 | ||
| S100 | ||
| S099 | ||
| S098 | 2018-11-14 | 30-day Notice |
| S097 | 2018-09-27 | 30-day Notice |
| S096 | 2018-09-26 | Real-time Process |
| S095 | 2018-09-24 | Real-time Process |
| S094 | ||
| S093 | 2018-09-19 | 30-day Notice |
| S092 | 2018-08-27 | 30-day Notice |
| S091 | 2018-06-25 | 30-day Notice |
| S090 | 2018-04-19 | 30-day Notice |
| S089 | 2018-04-19 | 30-day Notice |
| S088 | 2018-01-16 | 30-day Notice |
| S087 | 2018-01-16 | 30-day Notice |
| S086 | 2018-01-08 | 30-day Notice |
| S085 | 2017-11-22 | 30-day Notice |
| S084 | 2017-11-22 | 30-day Notice |
| S083 | 2017-08-21 | Special (immediate Track) |
| S082 | 2017-08-18 | 30-day Notice |
| S081 | 2017-08-07 | Real-time Process |
| S080 | 2017-06-29 | Real-time Process |
| S079 | 2017-05-15 | 30-day Notice |
| S078 | 2017-03-08 | 30-day Notice |
| S077 | 2017-03-02 | 30-day Notice |
| S076 | 2017-02-06 | 135 Review Track For 30-day Notice |
| S075 | 2017-02-02 | Real-time Process |
| S074 | 2016-12-05 | 30-day Notice |
| S073 | 2016-11-29 | 30-day Notice |
| S072 | 2016-11-21 | 30-day Notice |
| S071 | 2016-10-28 | 30-day Notice |
| S070 | 2016-10-06 | 30-day Notice |
| S069 | 2016-09-29 | 135 Review Track For 30-day Notice |
| S068 | 2016-09-29 | 30-day Notice |
| S067 | 2016-09-19 | Real-time Process |
| S066 | 2016-07-05 | 30-day Notice |
| S065 | 2016-06-22 | Real-time Process |
| S064 | 2016-06-06 | 30-day Notice |
| S063 | 2016-05-05 | 30-day Notice |
| S062 | 2016-04-22 | 135 Review Track For 30-day Notice |
| S061 | 2015-09-30 | Special (immediate Track) |
| S060 | 2015-06-05 | 30-day Notice |
| S059 | 2015-04-08 | 30-day Notice |
| S058 | 2015-03-16 | 30-day Notice |
| S057 | 2015-03-09 | 30-day Notice |
| S056 | 2015-02-27 | 135 Review Track For 30-day Notice |
| S055 | 2015-01-12 | 30-day Notice |
| S054 | 2015-01-09 | Real-time Process |
| S053 | 2014-11-03 | Real-time Process |
| S052 | 2014-10-20 | 30-day Notice |
| S051 | 2014-07-01 | 135 Review Track For 30-day Notice |
| S050 | 2014-01-10 | Normal 180 Day Track No User Fee |
| S049 | 2013-12-05 | 30-day Notice |
| S048 | 2013-04-09 | 30-day Notice |
| S047 | 2012-11-06 | Real-time Process |
| S046 | 2012-09-25 | Real-time Process |
| S045 | 2012-09-10 | 30-day Notice |
| S044 | 2012-07-03 | 30-day Notice |
| S043 | 2012-04-17 | 30-day Notice |
| S042 | 2012-04-02 | 30-day Notice |
| S041 | 2012-03-07 | Normal 180 Day Track |
| S040 | 2012-01-18 | Real-time Process |
| S039 | 2011-09-28 | 30-day Notice |
| S038 | 2011-08-22 | 30-day Notice |
| S037 | 2011-06-09 | Normal 180 Day Track |
| S036 | 2011-03-23 | 135 Review Track For 30-day Notice |
| S035 | ||
| S034 | 2010-11-26 | 30-day Notice |
| S033 | 2010-11-18 | Special (immediate Track) |
| S032 | 2010-11-17 | 30-day Notice |
| S031 | 2010-11-15 | Normal 180 Day Track |
| S030 | ||
| S029 | 2010-07-27 | 30-day Notice |
| S028 | 2010-03-26 | 30-day Notice |
| S027 | 2010-01-19 | 30-day Notice |
| S026 | 2009-07-14 | 30-day Notice |
| S025 | 2009-07-08 | 30-day Notice |
| S024 | 2009-05-08 | Real-time Process |
| S023 | 2009-03-09 | 30-day Notice |
| S022 | 2009-02-11 | 30-day Notice |
| S021 | 2009-02-11 | 30-day Notice |
| S020 | 2009-01-15 | 30-day Notice |
| S019 | 2008-09-05 | 30-day Notice |
| S018 | 2008-07-02 | 30-day Notice |
| S017 | 2008-07-01 | 30-day Notice |
| S016 | ||
| S015 | 2008-04-25 | 30-day Notice |
| S014 | 2007-12-26 | 30-day Notice |
| S013 | 2007-10-09 | 30-day Notice |
| S012 | 2007-10-01 | 30-day Notice |
| S011 | 2007-09-24 | 30-day Notice |
| S010 | 2007-07-02 | 135 Review Track For 30-day Notice |
| S009 | 2007-06-28 | 30-day Notice |
| S008 | 2007-03-22 | 30-day Notice |
| S007 | 2006-12-26 | Normal 180 Day Track No User Fee |
| S006 | 2006-11-06 | 30-day Notice |
| S005 | 2005-01-04 | Normal 180 Day Track |
| S004 | 2004-03-11 | Real-time Process |
| S003 | 2004-03-02 | 30-day Notice |
| S002 | 2004-01-15 | Real-time Process |
| S001 | 2003-05-27 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00878953000718 | P000053 | 000 |
| 00878953000824 | P000053 | 000 |
| 00878953000817 | P000053 | 000 |
| 00878953000800 | P000053 | 000 |
| 00878953000794 | P000053 | 000 |
| 00878953000787 | P000053 | 000 |
| 00878953000770 | P000053 | 000 |
| 00878953000763 | P000053 | 000 |
| 00878953000756 | P000053 | 000 |
| 00878953000749 | P000053 | 000 |
| 00878953000732 | P000053 | 000 |
| 00878953004938 | P000053 | 000 |
| 00878953005461 | P000053 | 000 |
| 00878953000725 | P000053 | 000 |
| 00878953000619 | P000053 | 000 |
| 00878953000626 | P000053 | 000 |
| 00878953000633 | P000053 | 000 |
| 00878953000688 | P000053 | 000 |
| 00878953003085 | P000053 | 005 |
| 00878953003092 | P000053 | 005 |
| 00878953003191 | P000053 | 005 |
| 00878953003184 | P000053 | 005 |
| 00878953003177 | P000053 | 005 |
| 00878953003160 | P000053 | 005 |
| 00878953003153 | P000053 | 005 |
| 00878953003146 | P000053 | 005 |
| 00878953003139 | P000053 | 005 |
| 00878953003122 | P000053 | 005 |
| 00878953003115 | P000053 | 005 |
| 00878953003108 | P000053 | 005 |
| 00878953003078 | P000053 | 005 |
| 00878953005652 | P000053 | 024 |