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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 SACRAL NERVE STIMULATION SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable electrical stimulator for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS001
Date Received10/29/1997
Decision Date10/31/1997
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic(r) model 041826 self-adhesive ground pad bulk accessory.
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