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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 NameTEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable system for sacral nerve stimulation
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP970004
Supplement NumberS155
Date Received04/26/2013
Decision Date10/22/2013
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling and product specification related to the use of diagnostic ultrasound imaging to help guide the insertion of the foramen needle into one of the sacral foramina during the acute test stimulation procedure.
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