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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 NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432
PMA NumberP970004
Supplement NumberS392
Date Received11/09/2023
Decision Date12/12/2023
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
implementation of updates to the H3 battery cathode mix manufacturing chloride specification and associated testing method for the InterStim Therapy System,Verify Evaluation System
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