FDA.reportPublic FDA data

PMA P830055S257

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S257
Product code
NJL
Decision date
2020-10-21
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for a manufacturing site located at Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou Jiangsu, China, to manufacture Sigma PS Femur components of the LCS Total Knee System.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S257
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-10-21
Decision code
APPR
Date received
2020-09-22
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou Jiangsu, China, to manufacture Sigma PS Femur components of the LCS Total Knee System.