PMA P240020

Device: TOUCH® CMC 1 Prosthesis
Applicant: Keri Medical SA
Product code: SFA
Decision date: 2026-05-12
Generic name: Prosthesis, finger, semi-constrained, metal/polymer
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.

Current openFDA PMA Record#

Device: TOUCH® CMC 1 Prosthesis
Applicant: Keri Medical SA
PMA number: P240020
Supplement: S004
Product code: SFA
Generic name: Prosthesis, finger, semi-constrained, metal/polymer
Decision date: 2026-05-12
Decision code: APPR
Date received: 2025-11-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.