AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment

Device, Incontinence, Mechanical/hydraulic

FDA Premarket Approval P000053 S108

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

A process change to add the boston scientific st. Paul facility as an alternate manufacturing site for silicone molded components

DeviceAMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment
Classification NameDevice, Incontinence, Mechanical/hydraulic
Generic NameDevice, Incontinence, Mechanical/hydraulic
ApplicantBoston Scientific Corp.
Date Received2019-10-31
Decision Date2019-11-27
PMAP000053
SupplementS108
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
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

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.