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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, Verify® Evaluation System
Generic NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MS RCW225
MINNEAPOLIS, MN 55432
PMA NumberP080025
Supplement NumberS239
Date Received09/13/2021
Decision Date08/30/2022
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to the labeling to prevent migration of the percutaneous extension connector.
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