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Re: slopak post# 81454

Wednesday, 08/10/2016 9:07:12 AM

Wednesday, August 10, 2016 9:07:12 AM

Post# of 330343
Tsunami + with the FDA "Red Carpet" Your fooling yourself if you don't believe FDA showed up with an army of staff for a tea party. The review for device II approvals in neuro-modulation needed to be more specific in the circumstances...

the examiners have agreed to exclusively review the back pain data from our UK Registry studies. Some of this data is peer reviewed and published. We have approximately 4,500 subject’s responses, who used the trial device for musculoskeletal back pain, as well as data on over 100 subjects demonstrating the durability of therapy over a 6 month study period for back pain.