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PMA P830055S261

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S261
Product code
NJL
Decision date
2020-12-21
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Manufacturing site located at Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou Jiangsu, China, to manufacture ATTUNE Revision Stem components of the LCS Total Knee System.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S261
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-12-21
Decision code
APPR
Date received
2020-11-23
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing site located at Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou Jiangsu, China, to manufacture ATTUNE Revision Stem components of the LCS Total Knee System.