PMA P830055S243
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S243
- Product code
- NJL
- Decision date
- 2020-04-22
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Change in Chemical Formulation and Cleaning Detergent for Final Cleaning Process for several Knee components.
Current openFDA PMA Record#
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S243
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-04-22
- Decision code
- OK30
- Date received
- 2020-03-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in Chemical Formulation and Cleaning Detergent for Final Cleaning Process for several Knee components.