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Lifecore seeks FDA dispute panel review for Intergel

This article was originally published in Clinica

Executive Summary

Lifecore Biomedical plans to pursue formal dispute resolution via the US FDA's Medical Devices Dispute Resolution Panel (MDDRP) over the PMA application for its ferric hyaluronate product, Gynecare Intergel adhesion prevention solution. The product is designed to reduce post-surgical adhesion formation after gynaecological laparotomy procedures.

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