Use of an alternate flow meter to be used during the testing of the devices¿ control pump and the use of an alternate disinfectant cleaner for sanitization of the device tester.
| Device | AMS 800 ARTIFICAL URINARY SPHINCTER (AUS) |
| Classification Name | Device, Incontinence, Mechanical/hydraulic |
| Generic Name | Device, Incontinence, Mechanical/hydraulic |
| Applicant | Boston Scientific Corp. |
| Date Received | 2009-03-09 |
| Decision Date | 2009-04-08 |
| PMA | P000053 |
| Supplement | S023 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices