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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.
 
DeviceSNS BOWEL EXTENSIONS, SNS BOWEL LEADS
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 NumberS054
Date Received09/09/2013
Decision Date10/03/2013
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
UPDATES TO THE CURRENT FINAL PACKLABEL PRINTING EQUIPMENT CONTROLLER, WHICH IS USED DURING THE STERILE FINAL PACKAGE OPERATION ATMEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) IN VILLALBA, PUERTO RICO.
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