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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.
 
DeviceMEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432
PMA NumberP970004
Supplement NumberS033
Date Received09/30/2005
Decision Date06/30/2006
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE INTERSTIM NEUROSTIMULATOR (MODEL 3058 INTERSTIM II), PATIENT PROGRAMMER (MODEL 3037 ICON), THERAPY APPLICATION SOFTWARE, TINED LEADS (MODELS 3889/3093), SYSTEM ACCESSORIES (MODEL 37092 EXTERNAL ANTENNA, TORQUE HEX WRENCH, TUNNELING TOOL), AND LABELING ARCHITECTURE.
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