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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/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.
 
DeviceAMS SPHINCTER 800 URINARY CONTROL SYSTEM
Generic Namedevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberP000053
Date Received12/19/2000
Decision Date06/14/2001
Product Code EZY 
Docket Number 01M-0579
Notice Date 12/21/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 
S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 
S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 
S087 S088 S089 S090 S091 S092 S093 S095 S096 S097 S098 S100 
S101 S102 S103 S104 S105 S106 S107 S108 S109 S110 S111 S112 
S113 S114 S115 S116 S117 S118 S119 S120 S121 S123 S124 S125 
S126 S127 S128 
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