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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAgili-C
Generic NameImplant, resorbable, for articular osteochondral repair
ApplicantSmith and Nephew, Inc.
150 Minuteman Rd.
Andover, MA 01810
PMA NumberP210034
Supplement NumberS001
Date Received12/11/2025
Decision Date06/04/2026
Product Code QRU 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updated package labeling that incorporates the clinical results from the required postapproval study.
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