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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
PMA NumberP030017
Supplement NumberS185
Date Received11/22/2013
Decision Date03/07/2014
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the precision spectra observational mechanical gateway (omg) to be used as an adjunct accessory with the precision spectra spinal cord stimulator (scs) system.