AMS SPHINCTER 800 URINARY CONTROL SYSTEM

Device, Incontinence, Mechanical/hydraulic

FDA Premarket Approval P000053

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the ams sphincter 800(tm) urinary prosthesis. The device is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.

• Device: AMS SPHINCTER 800 URINARY CONTROL SYSTEM
• Classification Name: Device, Incontinence, Mechanical/hydraulic
• Generic Name: Device, Incontinence, Mechanical/hydraulic
• Applicant: Boston Scientific Corp.
• Date Received: 2000-12-19
• Decision Date: 2001-06-14
• Notice Date: 2001-12-21
• PMA: P000053
• Supplement: S
• Product Code: EZY
• Docket Number: 01M-0579
• Advisory Committee: Gastroenterology/Urology
• Expedited Review: No
• Combination Product: No
• Applicant Address: Boston Scientific Corp. 100 Boston Scientific Way marlborough, MA 01752
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

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

Device ID	PMA	Supp
00878953000718	P000053	000
00878953000824	P000053	000
00878953000817	P000053	000
00878953000800	P000053	000
00878953000794	P000053	000
00878953000787	P000053	000
00878953000770	P000053	000
00878953000763	P000053	000
00878953000756	P000053	000
00878953000749	P000053	000
00878953000732	P000053	000
00878953004938	P000053	000
00878953005461	P000053	000
00878953000725	P000053	000
00878953000619	P000053	000
00878953000626	P000053	000
00878953000633	P000053	000
00878953000688	P000053	000
00878953003085	P000053	005
00878953003092	P000053	005
00878953003191	P000053	005
00878953003184	P000053	005
00878953003177	P000053	005
00878953003160	P000053	005
00878953003153	P000053	005
00878953003146	P000053	005
00878953003139	P000053	005
00878953003122	P000053	005
00878953003115	P000053	005
00878953003108	P000053	005
00878953003078	P000053	005
00878953005652	P000053	024