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.
Alternate mixing vessel to be used in the manufacture of a solution.
Device | AMS 800 ARTIFICIAL URINARY SPHINCTER |
Classification Name | Device, Incontinence, Mechanical/hydraulic |
Generic Name | Device, Incontinence, Mechanical/hydraulic |
Applicant | Boston Scientific Corp. |
Date Received | 2009-02-11 |
Decision Date | 2009-03-19 |
PMA | P000053 |
Supplement | S022 |
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 |
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 |