FDA.reportPublic FDA data

PMA P830055S248

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S248
Product code
NJL
Decision date
2020-06-15
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Re-sequencing/consolidating manufacturing steps to align the Raynham, USA manufacturing site with the approved Cork, Ireland manufacturing site and the change of the manual box buffing touch-up operation to an optional per the visual inspection to meet the finish drawing specifications.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S248
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-06-15
Decision code
OK30
Date received
2020-05-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Re-sequencing/consolidating manufacturing steps to align the Raynham, USA manufacturing site with the approved Cork, Ireland manufacturing site and the change of the manual box buffing touch-up operation to an optional per the visual inspection to meet the finish drawing specifications.