PMA P830055S298

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
Product code: NJL
Decision date: 2022-10-27
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Implement a Robotic Process Automation (RPA) for the Sterilization Certificate approval process, which applies to LCS Total Knee System manufactured at Johnson and Johnson Medical (Suzhou) LTD in China.

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S298
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-10-27
Decision code: OK30
Date received: 2022-09-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a Robotic Process Automation (RPA) for the Sterilization Certificate approval process, which applies to LCS Total Knee System manufactured at Johnson and Johnson Medical (Suzhou) LTD in China.