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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 MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM; MRI 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 NumberS255
Date Received07/20/2016
Decision Date10/18/2016
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternate qualified supplier for the coil connector used in the above referenced implantable pulse generators (IPGs), as well as minor design changes to the coil connector and the connector block to accommodate the new supplier manufacturing process.
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