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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 THERAPY
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS049
Date Received02/26/2008
Decision Date04/24/2008
Product Code EZW 
Advisory Committee Gastroenterology
Supplement TypeReal-Time Process
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 LABELING CHANGES TO THE TECHNICAL MANUAL FOR THE TEST STIMULATION LEAD KIT AND TEST STIMULATION LEAD (MODEL 3065U AND MODEL 3057, RESPECTIVELY) TO EXPLICITLY DESCRIBE THE PRACTICE OF IMPLANTING TWO TEMPORARY TEST STIMULATION LEADS DURING A SINGLE BILATERAL PLACEMENT PROCEDURE FOR SEQUENTIAL TESTING WITHIN THE SEVEN DAY TRIAL PERIOD.
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