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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 SACRAL NERVE STIMULATION SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS009
Date Received04/21/2000
Decision Date10/18/2000
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3095a lead extension kit for use with the medtronic(r) interstim(r) system for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequendy in patients who have failed or could not tolerate more conservative treatments.
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