PMA P830055S236
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S236
- Product code
- NJL
- Decision date
- 2019-12-23
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Approval for minor changes in labeling for instructions for use (IFU).
Current openFDA PMA Record#
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S236
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-12-23
- Decision code
- APPR
- Date received
- 2019-09-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for minor changes in labeling for instructions for use (IFU).