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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 THERAPY FOR BOWEL CONTROL
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP080025
Supplement NumberS074
Date Received06/27/2014
Decision Date07/25/2014
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
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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