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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.
 
DeviceSNS URINARY INS INTERSTIM FAMILY
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue, n.e.
minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS146
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 - manufacturer/sterilizer/packager/supplier
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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