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Legal News

: Lawyers and Settlements

Failed CD Horizon System Fast-Tracked to Approval, Manufacturer Played by the Rules

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Washington, DC: The recall almost two years ago of the Medtronic CD Horizon Spinal System Agile Dynamic Stabilization Device was initiated literally months after the device was approved by the US Food and Drug Administration (FDA). And because the Medtronic CD Horizon system was substantially similar to other devices already on the market, manufacturer Medtronic Sofamor Danek did not require approval of a pre-market approval application (PMA) for its Class II medical device.

Full post as published by Lawyers and Settlements on September 22, 2009 (boomark / email).

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