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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 SPINAL CORD STIMULATION (SCS) SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS093
Date Received12/24/2014
Decision Date07/06/2015
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1) ADDITION OF THE PENTA LEAD TO THE PROTÉGÉ MRI NEUROSTIMULATION SYSTEM AND RELATED LABELING CHANGES; AND 2) REMOVAL OF A WARNING CONCERNING A PATIENT WITH A FEVER UNDERGOING AN MRI SCAN.
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