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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.
 
DeviceMEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS002
Date Received02/27/1998
Decision Date07/08/1998
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 marketing the Medtronic InterStim(R) Model 3023 Implantable Pulse Generator (IPG) and its control devices (model 3031 Patient Programmer with Model 7440 Optional antenna and Model 3051 Software Cartridge Memory Module (MemMod(R)) and is indicated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.
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