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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.
 
Trade NameSPINAL CORD STIMULATION
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
PMA NumberP840001
Supplement NumberS105
Date Received12/21/2007
Decision Date01/17/2008
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of an insert-molded process to manufacture the bond pad array (bpa) in place of a press-fit manufacturing method.
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