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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 NumberS029
Date Received08/30/2004
Decision Date08/04/2005
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) shipment of patient cable (model 041831) after manufacturing to medtronic neurological division, sullivan lake facility, minneapolis, minnesota, for cleaning, packaging and ethylene oxide sterilization, 2) extension of the current 2-year shelf life of the patient cable to 4 years using ethylene oxide sterilization and 3) labeling changes that involve combining the separate manuals for the model 3065u kit and the model 3057 lead into one manual and to replace the combined manual for models 041831, 041829, 041828, 041827 and 041826 with separate single sheet ifus (information for use).