Implementation of alternative automated manufacturing mixing equipment.
Device | AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT |
Classification Name | Device, Incontinence, Mechanical/hydraulic |
Generic Name | Device, Incontinence, Mechanical/hydraulic |
Applicant | Boston Scientific Corp. |
Date Received | 2015-01-12 |
Decision Date | 2015-02-12 |
PMA | P000053 |
Supplement | S055 |
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 | Yes |
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