Integrum AB granted PMA (premarket approval) by the FDA for the OPRA[™]Implant System
Integrum is both extremely pleased, and proud, to announce the PMA approval issued by the Food and Drug Administration (FDA) in the US for the OPRA[TM] Implant System as a class III medical device. Integrum is both extremely pleased, and proud, to announce the PMA approval issued by the Food and Drug Administration (FDA) in the US for the OPRA[TM] Implant System as a class III medical device. In a release posted by FDA today, the agency stated: “Today’s approval of the OPRA Implant System expands options for prostheses for individuals who have had above-the-knee