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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 ACCESSIRUES, EXTENSION , LEADS NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY, SCREENING TRIALING SYSTEMS
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 NumberS057
Date Received09/23/2013
Decision Date10/22/2013
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS.
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