PMA P110008S015

Device: coflex® Interlaminar Technology
Applicant: Companion Spine France
PMA number: P110008
Supplement: S015
Product code: NQO
Decision date: 2026-05-22
Classification: Orthopedic
Generic name: Prosthesis, spinous process spacer/plate
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.

Current openFDA PMA Record#

Device: coflex® Interlaminar Technology
Applicant: Companion Spine France
PMA number: P110008
Supplement: S015
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2026-05-22
Decision code: APPR
Date received: 2026-04-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.