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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 NameINTERSTIM THERAPY FOR URINARY CONTROL
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable system for sacral nerve stimulation
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP970004
Supplement NumberS073
Date Received04/29/2009
Decision Date10/26/2009
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 changes to the existing model 3093 and model 3889 interstim tined leads, the addition of an alternative stylet design to be included in the model 3093 and model 3889 leads kits, and a minor revision to the labeling to update the list of package contents for the model 3093 and model 3889 leads kits.
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