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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 SPECTRA SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS201
Date Received06/02/2014
Decision Date08/28/2014
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 A CHANGE TO THE PRECISION SPECTRA OBSERVATIONALMECHANICAL GATEWAY (OMG) DIRECTIONS FOR USE. THE PROPOSED CHANGE IS TO ADD THE ST JUDE PENTA LEAD (MODEL # 3228) TO THE TABLE OF COMPATIBLE ST. JUDE LEADS IN THE DIRECTIONS FOR USE. IN ADDITION, A STATEMENT WAS ADDED TO THE INTENDED USE SECTION TO REFER TO THE PRECISION SPECTRA SYSTEM MANUALS FOR THE INDICATIONS AND CONTRAINDICATIONS.
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