Sweden-based medical device company Integrum AB (Nasdaq First North Growth Market: INTEG B) announced on Monday that it has conducted a pre-submission meeting with the US Food and Drug Administration (FDA) to discuss regulatory pathways for the OPRA Implant System in transhumeral (above elbow) amputations.
Following this meeting, Integrum intends to submit a Pre-Market Approval (PMA) application based on existing clinical data.
Having secured PMA for transfemoral (above-knee) amputations in December 2020, Integrum aims to expand regulatory approval to include transhumeral amputations in the US. Following a recent FDA meeting and internal analysis, Integrum believes existing clinical data may suffice for PMA qualification. The company plans to submit the application in the first half of 2024.
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