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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 NamePRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantADVANCED BIONICS CORP.
PMA NumberP030017
Supplement NumberS002
Date Received06/09/2004
Decision Date10/01/2004
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model sc-1110 implanted pulse generator (ipg), the model sc-5110 external trial stimulator (ets), the model sc-5210 remote control and updates to the clinician programmer.
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