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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.
 
DeviceDIAM­™ Spinal Stabilization System
Generic NameProsthesis, spinous process spacer/plate
ApplicantCompanion Spine France Sas
Immeuble Le Bridge 5
5 Allee Des Acacias
Merignac 33 700
PMA NumberP240043
Supplement NumberS001
Date Received01/29/2026
Decision Date04/01/2026
Product Code NQO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a shelf-life extension from 1-year to 5-years for the DIAM™ Spinal Stabilization System. Based upon the information submitted, the PMA supplement is approved.
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