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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS137
Date Received06/22/2012
Decision Date07/17/2012
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
USE OF A MODIFIED GROSS LEAD DETECTION METHOD FOR THE IMPLANTABLE PULSE GENERATOR (IPG).
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