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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 NumberS003
Date Received08/03/1998
Decision Date11/02/1998
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(R) Model 3057 Test Stimulation Lead Bulk Accessory/Medtronic(R) Model 3065U Test Stimulation Lead Kit for use with the Medtronic(R) Interstim(R) Continence Control System which is inidcated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.
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