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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.
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
7000 central avenue ne
ms rcw225
minneapolis, MN 55432
PMA NumberP080025
Supplement NumberS046
Date Received02/06/2013
Decision Date04/18/2014
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for medtronics verify evaluation system, which is a test stimulation system consisting of the model 3537 controller, the model 3531 verify external neurostimulator (ens), and associated cables (models 3575 and 3576) and accessories.