PMA P240020S001

Device: TOUCH® CMC 1 Prosthesis
Applicant: Keri Medical SA
PMA number: P240020
Supplement: S001
Product code: SFA
Decision date: 2025-09-05
Classification: Orthopedic
Generic name: Prosthesis, finger, semi-constrained, metal/polymer
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.

Current openFDA PMA Record#

Device: TOUCH® CMC 1 Prosthesis
Applicant: Keri Medical SA
PMA number: P240020
Supplement: S001
Product code: SFA
Generic name: Prosthesis, finger, semi-constrained, metal/polymer
Decision date: 2025-09-05
Decision code: APPR
Date received: 2025-08-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.