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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.
 
Devicecoflex® Interlaminar Technology
Generic NameProsthesis, spinous process spacer/plate
ApplicantCompanion Spine France
Immeuble Le Bridge - 5 Allee Des Acacias
Merignac Gironde 33700
PMA NumberP110008
Supplement NumberS015
Date Received04/24/2026
Decision Date05/22/2026
Product Code NQO 
Advisory Committee Orthopedic
Clinical TrialsNCT00534235
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested termination of study enrollment and subject follow-up for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P110008. Based upon the information submitted, the PMA supplement is approved.
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