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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 CORP.
PMA NumberP030017
Supplement NumberS137
Date Received06/22/2012
Decision Date07/17/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Use of a modified gross lead detection method for the implantable pulse generator (ipg).
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