Medtronic Infuse Bone Graft

Discussion in 'Industry Rumors' started by Anonymous, Apr 6, 2014 at 3:31 PM.

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  1. Anonymous

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  2. Anonymous

    Anonymous Guest

    There is no "Off-label" use with Infuse bone graft/Lt-Cage unless they're using the combination product intact. You can't unbundle the LT-Cage and replace it with another in the same manner you can't take the mother board of a pacer maker and replacement with some board from another mfr. PMA 000054 is a class III combination product, but once you change any of the components that impacts safety and effectiveness, the device is adulterated and misbranded until new PMA supplement is issued. Off-label only refers to a device being with all of its approved components intact. In 2007 FDA placed into law 21 CFR 888.3080 which effectively prohibits the combination of biologics and spinal cages without first obtaining PMA. But MDT has gotten away with selling their biologic with anything but the LT-Cage for over a decade now, and FDA is simply ignoring their own law.