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Re: RockoTaco post# 127654

Sunday, 05/30/2021 8:11:21 PM

Sunday, May 30, 2021 8:11:21 PM

Post# of 140475
This is per fda what vicarious can now do w breakthrough designation:

Participants granted a Breakthrough Device Designation will have opportunities to interact with appropriate, specialized FDA review team members and senior management prior to submitting their device for FDA approval and receive clear guidance on what is required for approval and how requirements can be met.


Titan is way past this and already has clear guidance and has been in constant communication w fda.