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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 NumberS004
Date Received11/21/2025
Decision Date05/12/2026
Product Code SFA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional manufacturing sterilization site located at Synergy Health Marseille SAS, Les Arnavaux, Rue Jean Queillau Marseille 14, 14 Provence-Alpes-Cote d'Azur, FR 13323.
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