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For the purposes of the device pass-through evaluation process, CMS evaluates the nominated device that is the subject of an application, not a category of devices, to determine if the device meets the eligibility criteria described in 419.66

The tissue lacks the robust blood supply that muscles enjoy, receives constant mechanical loading that disrupts healing, and often develops fibrotic scar tissue rather than healthy organized collagen

2019 May 27;3(2):200-214