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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.
 
DeviceVERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS187
Date Received12/29/2014
Decision Date06/26/2015
Product Code EZW 
Advisory Committee Gastroenterology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MODEL 3579 CABLE AND MODEL 3676 CABLE AND ASSOCIATED CHANGES TO ENABLE USE OF THE APPROVED VERIFY¿ EVALUATION SYSTEM WITH THE APPROVED TEMPORARY TEST STIMULATION LEADS.
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