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Cowboy200009

01/19/10 5:22 PM

#9175 RE: mr_sano #9174

I do not think it that easy or necessarily the issue! FDA's approvals do take time! And just giving the FDA what they want as part of DD is the important part of moving forward I would think! Questions are very common! Lots of questions very common! And a Professional Review again very common especially with these types of devices! IMO!