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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, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030017
Supplement NumberS157
Date Received03/04/2013
Decision Date05/30/2013
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an updating to the clinician programmer computer used with the precision and precision spectra spinal cord stimulator (scs) systems. A tablet computer from asus, model eee slate b121, will be used to replace the current clinician programmer, a toshiba model m400 laptop computer. The asus tablet is an off-the-shelf computer, customized to be a clinicians programmer by installing the eee slate b121 boot and image software and configuring the system with the bn1. 2 and bn3 bionicnavigator software.
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