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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 FAMILY OF IMPLANTABLE NEUROSTIMULATORS
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable system for sacral nerve stimulation
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP970004
Supplement NumberS123
Date Received07/22/2011
Decision Date08/17/2011
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Update the software used at several medtronic¿s manufacturing facilities.
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