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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.
 
DeviceGENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Abbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS050
Date Received04/18/2012
Decision Date06/26/2013
Product Code LGW 
Advisory Committee Neurology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF SEVERAL PIECES OF EQUIPMENT THAT ARE NEW TO THE MANUFACTURING PROCESS AS WELL AS THE RELOCATION OF EQUIPMENT AND THE ADDITION OF AN ALREADY APPROVED PIECE OF EQUIPMENT TO THE BILBY ROAD FACILITY LOCATION.
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