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Imricor Says US FDA Accepts Premarket Approval Submission Manufacturing Module, Shares Jump 3%

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Imricor Medical Systems (ASX:IMR) received notification from the US Food and Drug Administration (FDA) that the regulator completed its evaluation of the manufacturing module of the firm's premarket approval submission, and that the module has been accepted and is considered closed, according to a Thursday Australian bourse filing.

The module covers the design, manufacturing, and quality processes for seven products in total. Six of these are the firm's own products undergoing the premarket approval process, including the Vision-MR ablation catheter and the RF-5000 ablation generator and pump, as well as a third-party product that Imricor will distribute.

The FDA will also conduct a pre-approval inspection of the company's manufacturing sites before a final premarket approval.

Its shares rose 3% in recent trading on Thursday.

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