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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/INTERSTIM II NEUROSTIMULATOR
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP080025
Supplement NumberS002
Date Received04/04/2011
Decision Date05/04/2011
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of newly validated process parameters for the blister sealing machine at medtronic puerto rico operations company (mproc) located in juncos, puerto rico.
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