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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 Urinary Programming Systems)
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS322
Date Received11/04/2020
Decision Date02/02/2021
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for minor labeling changes to the MRI Guidelines for InterStim systems manual for the InterStim Micro and InterStim II systems used for Sacral Neuromodulation (SNM) therapy to treat urinary retention and the symptoms of overactive bladder, and chronic fecal incontinence.
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