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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 II IMPLANTABLE NEUROSTIMULATOR
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP080025
Supplement NumberS028
Date Received03/22/2012
Decision Date04/20/2012
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduce the sample size for parallel gap weld line testing on plated components.
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