PMA P910016S010
- Device
- Lcs(r)total Knee System
- Applicant
- DEPUY, INC.
- PMA number
- P910016
- Supplement
- S010
- Decision date
- 1998-01-15
Current openFDA PMA Record
- Device
- LCS(R)TOTAL KNEE SYSTEM
- Applicant
- Depuy, Inc.
- PMA number
- P910016
- Supplement
- S010
- Product code
- MBD
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Decision date
- 1998-01-15
- Decision code
- APPR
- Date received
- 1997-12-15
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the use of multilingual package labeling and a multilingual package insert for the components of the Unicompartmental Configuration of the LCS(R) Total Knee System.