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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.
 
DeviceRAPID PROGRAMMER
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS053
Date Received06/01/2012
Decision Date07/31/2012
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR UPGRADING THE RAPID PROGRAMMER SOFTWARE USED IN THE GENESIS AND EON FAMILY NEUROMODULATION STIMULATORS FROM VERSION 3.3 (MODEL 3831 AND 3832) TO VERSION 3.4 (MODEL 3834).
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