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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 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 SYSTEMS
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS125
Date Received07/29/2011
Decision Date08/26/2011
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER. THESE CHANGES INCLUDE THE ADDITION OR PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION. THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES.
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