FDA panel to review pre-market approval application for Medtronic’s spinal stabilization system: 3 notes

An FDA advisory panel will meet to consider Medtronic’s pre-market approval application for its DIAM spinal stabilization system, according to a Mass Device report.

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Here are three notes:

 

1. The FDA’s Orthopaedic & Rehabilitation Devices panel is slated to meet Feb. 19.

 

2. The DIAM (device for intervertebral assisted motion) system is designed to treat lower back pain from moderate lumbar degenerative disc disease, at a single level from the L2 to the L5 vertebrae.

 

3. The system has had CE Mark approval in the European Union for around 10 years.

 

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