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uksausage

06/26/18 10:11 AM

#143944 RE: markjohn62 #143940

they are separate activities - they can and will file the 501K for post operative use separate from the competition (which may then accelerate the application)

this has been confirmed by the company through official channels

It takes time to create a 501K application they have limited resources the Back one and extension to general muscular skeletal use took priority.

art2426

06/26/18 10:24 AM

#143951 RE: markjohn62 #143940

Thanks MJ, let us know if you get any more info from your questions to company. The pre/post operative use of patch is what I am very interested in. Let us laypeople (non medical) not underestimate the HUGE potential of this clearance. It would be something if this would turn out to be 'standard of care' in pre op, surgery and recovery room. Immense continuous revenue generated throughout the world.