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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.
 
DeviceTEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT
Generic NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Ms Rcw225
Minneapolis, MN 55432
PMA NumberP080025
Supplement NumberS051
Date Received04/26/2013
Decision Date10/22/2013
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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