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Imricor Medical Systems Says FDA Completes Review of PMA Module Three

MT Newswires Live
2 hours ago

Imricor Medical Systems (ASX:IMR) said the US Food and Drug Administration has completed its review of module three of the company's premarket approval (PMA) submission, which covers non-clinical bench testing for its Vision-MR ablation catheter 2.0, RF-5000 system and irrigation tubing set, according to a Thursday Australian bourse filing.

No deficiencies were identified in the catheter or tubing set, while one deficiency was found in the RF-5000 system's third-party software operating system, which the company has already upgraded to a long-term supported version, per the filing.

The company is preparing its response to the FDA, with module three expected to close upon acceptance and module four targeted for submission in November, thereby completing all PMA submissions, the filing added.

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