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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 NumberS055
Date Received06/06/2012
Decision Date10/25/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of stand-off tabs on the routed printed circuit board (pcb), to change the equipment used to route the pcbs, and to add kapton tape to the battery surface to prevent contact with copper traces from the pcb and the adjacent surface of the battery.