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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
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030017
Supplement NumberS128
Date Received01/31/2012
Decision Date02/29/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of clarifications to the existing visual inspection criteria for the feedthrough component of the implantable pulse generator (ipg).
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