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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.
 
DeviceINTERSTIM THERAPY FOR BOWEL CONTROL
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
ms rcw225
minneapolis, MN 55432
PMA NumberP080025
Supplement NumberS074
Date Received06/27/2014
Decision Date07/25/2014
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling to add a warning regarding the risk of increased or uncontrolled bleeding and the use of anticoagulants prior to surgery for interstim therapy.
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