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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 SYSTEM FOR URINARY CONTROL THERAPY
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namesacral nerve stimulation system
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS007
Date Received02/15/2000
Decision Date02/29/2000
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a quick guide to the model 3031 patient programmer that will be provided to implanting physicians for distribution to both currently implanted and future patients.
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