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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 BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
ms rcw225
minneapolis, MN 55432
PMA NumberP080025
Supplement NumberS071
Date Received05/30/2014
Decision Date06/27/2014
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an alternate supplier for a component of the battery.
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