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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 NameMEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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 S049 S050 S051 S052 S053 S054 S055 S056 
S057 S058 S059 S060 S061 S062 S063 S064 S065 
S066 S067 S069 S070 S071 S072 S073 S074 
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