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U.S. Department of Health and Human Services

Devices@FDA
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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 Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS385
Date Received06/12/2023
Decision Date11/22/2023
Product Code EZW 
Advisory Committee Gastroenterology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
approval for updates to the existing approved RS5200 Recharger Kit, WR9220 Recharger, and CD9000 Dock, including mechanical, hardware, manufacturing, firmware design, and labeling changes
  We welcome your comments and feedback about Devices@FDA.
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