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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAMS SPHINCTER 800 URINARY CONTROL SYSTEM
Classification Namedevice, incontinence, mechanical/hydraulic
Generic Nameurinary prosthesis
Regulation Number876.5280
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP000053
Date Received12/19/2000
Decision Date06/14/2001
Product Code
EZY[ Registered Establishments with EZY ]
Docket Number 01M-0579
Notice Date 12/21/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S031 S032 S033 S034 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 
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