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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) System
Generic NameProsthesis, spinous process spacer/plate
ApplicantBoston Scientific Neuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP140004
Supplement NumberS034
Date Received10/17/2024
Decision Date11/07/2024
Product Code NQO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
qualification of a new, controlled environment area at the manufacturing facility in Clonmel, Ireland
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