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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 (IDS)
Generic Nameprosthesis, spinous process spacer/plate
Applicant
Boston Scientific Neuromodulation
25155 rye canyon loop
valencia, CA 91355
PMA NumberP140004
Supplement NumberS025
Date Received07/30/2021
Decision Date08/26/2021
Product Code NQO 
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Distribute the device incorporating the change as requested in this supplement. This change applies to the final assembly of the Superion Indirect Decompression System (IDS) device. The following manufacturing facility is affected by the change: Boston Scientific Limited, Cashel Rd, ClonmelCo, Tipperary, Ireland.
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