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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 INTRODUCER
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantADVANCED BIONICS CORP.
PMA NumberP030017
Supplement NumberS022
Date Received04/04/2007
Decision Date07/18/2007
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an optional surgical tool called the introducer.
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