Brief: Titan Medical Provides Regulatory Update

Conavi Medical

30/12/2020 12:37

Dec 30 (Reuters) - Titan Medical Inc  TMD.TO :
    * TITAN MEDICAL PROVIDES REGULATORY UPDATE
    * TITAN MEDICAL - FDA HAS INDICATED THAT, BASED ON
INFORMATION
PROVIDED TO AGENCY, ENOS SYSTEM IS APPROPRIATE FOR
CLASSIFICATION THROUGH DE NOVO PATHWAY
    * TITAN MEDICAL - DO NOT ANTICIPATE OUR LIKELY PURSUIT OF DE
NOVO
PATHWAY WOULD MATERIALLY AFFECT OUR PREVIOUSLY STATED MILESTONES
OR BUDGETS FOR 2021
    * TITAN MEDICAL INC - WOULD LIKELY PROCEED WITH A DE NOVO
CLASSIFICATION REQUEST FOR ITS ENOS SYSTEM IN PLACE OF A 510(K)
SUBMISSION
    * TITAN MEDICAL INC - SHOULD FDA GRANT DE NOVO
CLASSIFICATION
REQUEST, CLASS II DEVICE WOULD BE CLEARED TO BE MARKETED

Source text for Eikon:  ID:nBwTjn0xa 
Further company coverage:  TMD.TO 

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