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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,PRECISION SPECTRA, PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEMS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS234
Date Received08/14/2015
Decision Date11/12/2015
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MINOR DESIGN CHANGE TO THE PLUG USED IN THE DISTAL TIP OF THE 1X16 INFINION LEADS TO MAKE THE TIP PLUG OF THE 1X16 INFINION LEAD SIMILAR TO THE TIP PLUG OF THE INFINION CX LEAD.
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