This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the ams sphincter 800(tm) urinary prosthesis. The device is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.
Device | AMS SPHINCTER 800 URINARY CONTROL SYSTEM |
Classification Name | Device, Incontinence, Mechanical/hydraulic |
Generic Name | Device, Incontinence, Mechanical/hydraulic |
Applicant | Boston Scientific Corp. |
Date Received | 2000-12-19 |
Decision Date | 2001-06-14 |
Notice Date | 2001-12-21 |
PMA | P000053 |
Supplement | S |
Product Code | EZY |
Docket Number | 01M-0579 |
Advisory Committee | Gastroenterology/Urology |
Expedited Review | No |
Combination Product | No |
Applicant Address | Boston Scientific Corp. 100 Boston Scientific Way marlborough, MA 01752 |
Summary: | Summary of Safety and Effectiveness |
Labeling: | Labeling Labeling Part 2 |
Post-Approval Study: | Show Report Schedule and Study Progress |
Approval Order: | Approval Order |
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 |