• Second module for PMA products submitted to FDA
• Module covers manufacturing processes across seven devices
• NorthStar 510(k) FDA application to be submitted next

Imricor Medical Systems, Inc. (ASX: IMR) has announced that it has submitted the second Premarket Approval (PMA) module for FDA review. The second module covers the design, manufacturing, and quality processes surrounding seven products in total, six of which are the company's own products undergoing the FDA's PMA approval process, and an additional third-party product that Imricor will distribute. This module includes items such as design controls, receipt, inspection and storage of raw materials, build procedures, process validation, part and device traceability, along with the applicable quality management systems. Imricor is executing a modular review process with the FDA, whereby modules covering various aspects of the company's products are submitted and reviewed serially, with the goal of achieving a more streamlined review process. In the background, the team has been working on the next PMA module, as well as the NorthStar 510(k) FDA application, which is slated for submission next. NorthStar will follow a 510(k) pathway, which involves a shorter review cycle, and Imricor expects to have this product commercially available in the US market in early Q3. The commercial launch in Europe is expected around the middle of the year.