AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment

FDA Premarket Approval P000053 S121

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for the addition of two sterilization chambers to conduct ethylene oxide gas sterilization cycle 101

DeviceAMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment
Generic NameDevice, Incontinence, Mechanical/hydraulic
ApplicantBoston Scientific Corp.
Date Received2021-06-11
Decision Date2021-07-08
PMAP000053
SupplementS121
Product CodeEZY 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 100 Boston Scientific Way marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P000053Original Filing
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

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