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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.
 
DeviceInterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems)
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 NumberS197
Date Received10/07/2019
Decision Date07/30/2020
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval of the new InterStim Micro System with 1.5T and 3T full-body MR conditional labeling, an updated InterStim II System (including new SureScan MRI leads) with 1.5T and 3T full-body MR conditional labeling, an updated Verify Evaluation System that can accommodate newly developed leads, and related labeling updates.
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