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U.S. Department of Health and Human Services

Devices@FDA
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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 IMPANTABLE INTERSTIM FAMILY
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS142
Date Received09/10/2012
Decision Date10/10/2012
Product Code EZW 
Advisory Committee Gastroenterology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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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