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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.
 
DeviceEON MINI IPG NEUROSTIMULATION SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS028
Date Received01/08/2009
Decision Date03/19/2009
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO, LLC, IN CAGUAS, PUERTO RICO.
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