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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable electrical stimulator for incontinence
Regulation Number876.5270
PMA NumberP970004
Date Received01/30/1997
Decision Date09/29/1997
Product Code
EZW[ Registered Establishments with EZW ]
Docket Number 98M-0037
Notice Date 01/29/1998
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the medtronic(r) interstim(r) sacral neve stimulation (sns)(tm) system which includes the model 3886 or 3080 lead, model 7495 extension, model 7424 implantable pulse generator (ipg), model 7455 memory module, model 7432 console programmer, model 7452 control magnet, model 3625 test stimulator (screener), and model 3065u pne kit and accessories. This device is indicated for the treatment of urinary urge incontinence in patient who have failed or could not tolerate more conservative treatments.
Post-Approval StudyShow Report Schedule and Study Progress
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