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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 STIMULATOR (SCS) SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantBOSTON SCIENTIFIC NEUROMODULATION CORPORATION
PMA NumberP030017
Supplement NumberS065
Date Received05/27/2008
Decision Date06/15/2010
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the bionic navigator software version 1. 2.
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