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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 NumberS134
Date Received05/07/2012
Decision Date12/21/2012
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PRECISION SPECTRA SYSTEM WHICH INCLUDES THE FOLLOWING COMPONENTS:1) MODEL SC-1132 PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR (LPG); 2)MODEL SC-440 I PRECISION SPECTRA LPG PORT PLUG; 3) MODEL SC-5132 PRECISION SPECTRA EXTERNAL TRIAL STIMULATOR; 4) MODEL SC-6360-32 PRECISION SPECTRA PATIENT TRIAL BELT; 4) MODEL SC-6500-32 PATIENT TRIAL KIT; 5) MODEL SC-5232 PRECISION SPECTRA REMOTE CONTROL; 6) MODEL SC-5532-1 PRECISION SPECTRA REMOTE CONTROL KIT; 7) MODEL NM-631 0 AND NM-621 0 USB POWER SUPPLY; AND 8) MODEL NM-621 0 REMOTE CONTROL HOLSTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRECISION SPECTRA SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS,INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
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