- Device
- LCS® Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S276
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2021-12-09
- Decision code
- APPR
- Date received
- 2021-11-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- requested approval to remove the re-sterilization instructions in the IFU for the LCS® Total Knee System