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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.
 
DeviceTOUCH® CMC 1 Prosthesis
Generic NameProsthesis, finger, semi-constrained, metal/polymer
ApplicantKeri Medical SA
Chemin Du Pre-Fleuri 5
1228 Plan-Les-Ouates 
PMA NumberP240020
Supplement NumberS001
Date Received08/07/2025
Decision Date09/05/2025
Product Code SFA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS), Continued Long-Term Follow-up Study. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240020.
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