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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 AND PRECISION SPECTRA 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 NumberS203
Date Received09/02/2014
Decision Date10/02/2014
Product Code LGW 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LABELING CHANGE TO BE MADE TO THE PRECISION AND PRECISION SPECTRA MANUALS. THE REQUESTED CHANGE ADDS SUPPLEMENTAL INFORMATION TO THE ADVERSE EVENTS SECTION OF THE MANUALS IN ORDER TO PROVIDE ADDITIONAL DETAILS ON THE POSSIBILITY OF THE FORMATION OF REACTIVE TISSUE AROUND THE LEAD IN THE EPIDURAL SPACE WHICH MAY RESULT IN DELAYED ONSET OF SPINAL CORD COMPRESSION AND NEUROLOGICAL/SENSORY DEFICIT INCLUDING PARALYSIS.
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