Lombard Medical submits fourth PMA module to FDA

Lombard Medical Technologies, a medical device company focused on solutions for abdominal aortic aneurysm (AAA) repair market, has submitted the fourth of six pre-market approval (PMA) modules required for the US approval of Aorfix by the US Food and Drug Administration (FDA).

Lombard Medical has FDA permission to file the PMA for Aorfix in a series of six modules and the first three of the modules on biological testing, non-clinical laboratory studies and, sterilisation and packaging have been reviewed and accepted by the FDA.

The fourth module on bench testing and shelf life has just been submitted and the company remains on track to file the fifth module on manufacturing before the end of the year and the final module containing the clinical data is expected to be filed in the first half of 2011.

Lombard Medical chief executive John Rush said that he was pleased that they continue to meet the timelines set out at the beginning of the year for submission of the various PMA modules required for FDA approval of Aorfix.