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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, n.e.
minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS153
Date Received03/07/2013
Decision Date04/15/2014
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling updates to incorporate the long-term data from the fecal incontinence post-approval study into the interstim therapy labeling.