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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
Generic NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Ms Rcw225
Minneapolis, MN 55432
PMA NumberP080025
Supplement NumberS092
Date Received04/20/2015
Decision Date10/04/2016
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a labeling update to incorporate data from the now completed, randomized 6 month cohort (Phase I) and 12 month data from the ongoing, nonrandomized study cohort (Phase II).
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