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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
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS211
Date Received12/22/2014
Decision Date01/21/2015
Advisory Committee Neurology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MOVING CONTACT PADDLE LEAD MANUFACTURING PROCESSES TO A BOSTON SCIENTIFIC FACILITY.
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