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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINTERSTIM THERAPY FOR UNINARY CONTROL
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS178
Date Received06/27/2014
Decision Date07/25/2014
Product Code EZW 
Advisory Committee Gastroenterology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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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