PMA P830055S279

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S279
Product code
NJL
Decision date
2022-01-20
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Introducing an additional Final Cleanline to the process for capacity purposes.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S279
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2022-01-20
Decision code
OK30
Date received
2022-01-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introducing an additional Final Cleanline to the process for capacity purposes.