PMA P910016S007
- Device
- NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
- Applicant
- Depuy, Inc.
- PMA number
- P910016
- Supplement
- S007
- Product code
- MBD
- Decision date
- 1996-01-02
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Approval order statement
- APPROVAL OF GAS PLASMA STERILIZATION FOR POLYETHYLENE COMPONENTS
Current openFDA PMA Record#
- Device
- NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
- Applicant
- Depuy, Inc.
- PMA number
- P910016
- Supplement
- S007
- Product code
- MBD
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Decision date
- 1996-01-02
- Decision code
- APPR
- Date received
- 1995-05-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL OF GAS PLASMA STERILIZATION FOR POLYETHYLENE COMPONENTS