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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
Regulation Number876.5270
PMA NumberP970004
Supplement NumberS003
Date Received08/03/1998
Decision Date11/02/1998
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for marketing the medtronic(r) model 3057 test stimulation lead bulk accessory/medtronic(r) model 3065u test stimulation lead kit for use with the medtronic(r) interstim(r) continence control system which is inidcated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.