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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.
 
DeviceSuperion® Indirect Decompression System
Generic Nameprosthesis, spinous process spacer/plate
Applicant
Boston Scientific Neuromodulation
25155 rye canyon loop
valencia, CA 91355
PMA NumberP140004
Supplement NumberS015
Date Received06/22/2018
Decision Date08/24/2018
Product Code NQO 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of three (3) manufacturing sites for Structure Medical, LLC, located at: 111 Cayuga Drive, Mooresville, North Carolina, 28117 to manufacture components in versions 1 and 2 (v1.0 and v2.0) of the Superion® implant; 9935 Business Circle, Naples, Florida, 34112 to manufacture components in v1.0 and v2.0 of the Superion® implant, assemby and final inspections of the implants; and, 3511 Plover Avenue, Naples, Florida 34117 for passivation activities of components in v1.0 and v2.0 of the Superion® implant.
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