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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 II NEUROSTIMULATOR
Generic NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MS RCW225
MINNEAPOLIS, MN 55432
PMA NumberP080025
Supplement NumberS025
Date Received12/21/2011
Decision Date01/20/2012
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
THERMAL PROCESSING OF ECCOBOND EPOXY RESIN E3450(A) PRIOR TO CONSUMPTION IN ROUTINE MANUFACTURING.
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