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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 NumberS390
Date Received09/28/2023
Decision Date12/18/2023
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
for labeling updates to the MRI Guidelines manual. The proposed labeling updates are to add the following: 1. MRI eligibility (full-body scans at 1.5T, 3T) criteria for abandoned lead fragments that may remain behind when explant is attempted. 2. MRI eligibility (head-only scans at 1.5T) criteria for a confirmed non-functional primary cell (non-rechargeable) implantable neurostimulator from Medtronic
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