FDA.reportPublic FDA data

PMA P830055S289

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S289
Product code
NJL
Decision date
2022-06-29
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
To replace the unsealed tanks for storing Porocoat® spray binder in a non-electrostatic spray booth and a electrostatic spray booth in the CoCrMo Porocoat® area, with a single sealed, pressurized storage tank with agitation.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S289
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2022-06-29
Decision code
APPR
Date received
2022-06-01
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
To replace the unsealed tanks for storing Porocoat® spray binder in a non-electrostatic spray booth and a electrostatic spray booth in the CoCrMo Porocoat® area, with a single sealed, pressurized storage tank with agitation.