Approval for the labeling change from 1. 5 tesla (1. 5t) magneticresonance imaging (mri) strength level to 3. 0 tesla (3. 0t) for the bundled ams products. The devices, as modified, will be marketed under the trade names: 1) ams 700 and ambicor inflatable penile prosthesis (ipp) are intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence); 2) ams 800 artificial urinary sphincter (aus) treats urinary incontinence due toreduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery; and 3) ams acticon neosphincter, artificial bowel sphincter (abs) is to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are notcandidates for, less invasive forms of restorative therapy.
| Device | AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) |
| Classification Name | Device, Incontinence, Mechanical/hydraulic |
| Generic Name | Device, Incontinence, Mechanical/hydraulic |
| Applicant | Boston Scientific Corp. |
| Date Received | 2012-11-06 |
| Decision Date | 2013-02-06 |
| PMA | P000053 |
| Supplement | S047 |
| Product Code | EZY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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