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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 NameMEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable electrical nerve stimulator
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS002
Date Received02/27/1998
Decision Date07/08/1998
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 interstim(r) model 3023 implantable pulse generator (ipg) and its control devices (model 3031 patient programmer with model 7440 optional antenna and model 3051 software cartridge memory module (memmod(r)) and is indicated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.
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