PMA P240043

Device: DIAM™ Spinal Stabilization System
Applicant: Companion Spine France Sas
Product code: NQO
Decision date: 2026-04-01
Generic name: Prosthesis, spinous process spacer/plate
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.

Current openFDA PMA Record#

Device: DIAM™ Spinal Stabilization System
Applicant: Companion Spine France Sas
PMA number: P240043
Supplement: S001
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2026-04-01
Decision code: APPR
Date received: 2026-01-29
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.