Imricor Medical Systems (ASX:IMR) submitted its second premarket approval module for US Food and Drug Administration (FDA) review, according to a Tuesday filing with the Australian bourse.
The module covers design, manufacturing, and quality processes for seven products, and includes design controls, raw material receipt, inspection, storage, build procedures, process validation, part and device traceability, and quality management systems, the filing said.
The company's NorthStar 3D mapping and guidance system will be submitted next under the 510(k) process.
Shares fell nearly 3% in morning trade Tuesday.
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