Approval for the addition of two sterilization chambers to conduct ethylene oxide gas sterilization cycle 101
| Device | AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment |
| Generic Name | Device, Incontinence, Mechanical/hydraulic |
| Applicant | Boston Scientific Corp. |
| Date Received | 2021-06-11 |
| Decision Date | 2021-07-08 |
| PMA | P000053 |
| Supplement | S121 |
| 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