| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | DIAM™ Spinal Stabilization System |
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| Generic Name | Prosthesis, spinous process spacer/plate |
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| Applicant | Companion Spine France Sas
Immeuble Le Bridge 5
5 Allee Des Acacias
Merignac 33 700 |
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| PMA Number | P240043 |
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| Date Received | 12/06/2024 |
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| Decision Date | 12/10/2025 |
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| Product Code |
NQO |
| Advisory Committee |
Orthopedic |
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| Clinical Trials | NCT00456378
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
The DIAM™ Spinal Stabilization System is indicated for skeletally mature patients that have moderate to severe primary low back pain (greater than leg pain) secondary to lumbar degenerative disc disease (DDD), at a single level from L2-L5 with current episode refractory to at least 6 months of non-operative care.Symptomatic disc disease is confirmed by patient history, physical examination, and radiographic evaluation with one or more of the following factors:• Greater than 2mm of decreased disc height (average disc height) compared to the adjacent level• Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule • Non-extruded herniated nucleus pulposusThe DIAM™ device is implanted via a minimally invasive posterior approach. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 |
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