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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.
 
DeviceMEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
ms rcw225
minneapolis, MN 55432
PMA NumberP080025
Date Received09/26/2008
Decision Date03/14/2011
Product Code
EZW[ Registered Establishments with EZW ]
Docket Number 11M-0175
Notice Date 03/31/2011
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE MEDTRONIC INTERSTIM THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF CHRONIC FECAL INCONTINENCE IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 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 S094 S095 S096 S097 S098 S099 S100 
S101 S102 S103 S104 S105 S106 S107 S108 S109 
S110 S111 S112 S113 S114 S115 S116 S117 S118 
S119 S120 S121 S122 S123 S124 S125 S126 S127 
S128 S129 S130 S131 S132 S133 S134 S135 S136 
S137 S138 S139 S140 S141 S142 S143 S144 S145 
S146 S147 S149 S150 S152 S153 S154 S155 
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