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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 SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant
Boston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP030017
Supplement NumberS212
Date Received01/26/2015
Decision Date02/25/2015
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
SUPPLIER RELOCATION OF PACKAGING AREAS AND COMPONENT MANUFACTURING PROCESS AREAS.
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