re the letter
Gil,
I think the FDA still is hanging with approving one level ADR at this point or has it yet gone to 2? Anyway, it sounds like this letter is stating it appears you have too many levels involved for ADR however a discogram might help decifer which level(s) seem to be truly problematic and perhaps you'd still fit in the parameters of acceptable for ADR at fusion (hybrid surgery) if only 2 levels were truly pain generators.
Or you could just skip wasting your time here and go to another country where the FDA does not deem who is fit for surgery and who isn't based on number of levels needing repair.
Either way you'll probably need a discogram to tell determine which levels to deal or how to approach the problem.
Just keep on searching for what seems right and viable for you to get done even if it takes a momentary pause to let these words settle in. This is just one surgeon, one facility.
Last edited by Maria; 05-12-2010 at 12:03 AM.
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