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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
PMA NumberP010032
Supplement NumberS013
Date Received12/21/2004
Decision Date05/11/2005
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of four models of the s-series lamitrode leads as accessories to the genesis family of neurostimulation ipg devices. The device, as modified, will be marketed under the trade name s-series lamitrode leads (model numbers3243, 3246, 3283 and 3286) and is indicated for use as the lead component of a spinal cord stimulation system. The spinal cord stimulation system is used to aid in the management of chronic pain of the trunk and/or extremities.