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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 (SNS Urinary)
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432
PMA NumberP970004
Supplement NumberS321
Date Received11/03/2020
Decision Date11/30/2020
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  
Addition of Meier Tool & Engineering (Meier Tool), Anoka, MN - USA as an alternate supplier for a battery component (second source) for the uncoated battery cathode current collector that is consumed into titanium coated cathode current collectors and eventually into the Delta 26H2 and Delta 26H3 medium rate batteries further used in implantable neurostimulators. And the addition of Incoming Inspection Procedures for Uncoated and Coated Cathode Current Collector Components Originating from Meier Tool.
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