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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSNS BOWEL INS INTERSTIM FAMILY
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP080025
Supplement NumberS042
Date Received11/13/2012
Decision Date03/27/2013
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the battery burn-in process and inspection methods.
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