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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.
 
DeviceNEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY
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 NumberS038
Date Received09/10/2012
Decision Date10/10/2012
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
USE OF THE NEW AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER SOFTWARE RELEASE, INTERFACING WITH THE MANUFACTURING EXECUTION SYSTEM AT THE HYBRID COMPONENT SUPPLIER.
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