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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAgili-C
Generic Nameimplant, resorbable, for articular osteochondral repair
ApplicantCartiHeal Ltd.
17 atir yeda street
kfar saba 44643
PMA NumberP210034
Date Received09/30/2021
Decision Date03/29/2022
Product Code QRU 
Docket Number 22M-0481
Notice Date 03/30/2022
Advisory Committee Orthopedic
Clinical TrialsNCT03299959
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for Agili-C. The Agili-C scaffold is indicated for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  
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