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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, PRECISION SPECTRA 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 NumberS202
Date Received06/30/2014
Decision Date12/19/2014
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PRECISION M8 ADAPTER THAT WILL BE USED TO CONNECT THE PRECISION IMPLANTABLE PULSE GENERATOR (IPG) OR THE PRECISION SPECTRA IPG TO THE FOLLOWING MEDTRONIC (MDT) SCS LEADS: SPECIFY 2X8 MODEL 39286, SPECIFY 5-6-5 MODEL 39565, LX8 COMPACT MODEL 3778, LX8 STANDARD MODEL 3777, LX8 SUB-COMPACT MODEL 3776, TEST: LX8, COMPACT MODEL 3874, TEST: LX8 STANDARD MODEL 3873, TEST: LX8 SUB-COMPACT MODEL 3875, MODEL 37081 EXTENSION, MODEL 37083 EXTENSION, MODEL 37082 EXTENSION, VECTRIS SURESCAN® MRI LX8 SUBCOMPACT, MODEL 977A160, 977A175, 977A190, AND VECTRIS SURESCAN® MRI LX8 COMPACT, MODEL 977A260, 977A275, 977A290.
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