PMA P240020S003

Device: TOUCH® CMC 1 Prosthesis
Applicant: Keri Medical SA
PMA number: P240020
Supplement: S003
Product code: SFA
Decision date: 2025-12-17
Classification: Orthopedic
Generic name: Prosthesis, finger, semi-constrained, metal/polymer
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240020

Current openFDA PMA Record#

Device: TOUCH® CMC 1 Prosthesis
Applicant: Keri Medical SA
PMA number: P240020
Supplement: S003
Product code: SFA
Generic name: Prosthesis, finger, semi-constrained, metal/polymer
Decision date: 2025-12-17
Decision code: APPR
Date received: 2025-11-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240020