PMA P830055S230
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S230
- Product code
- NJL
- Decision date
- 2019-05-17
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Manufacturing changes to the current in-process inspections of the ATTUNE CR and ATTUNE PS Femoral Components at the DePuy Raynham, Massachusetts manufacturing site.
Current openFDA PMA Record#
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S230
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-05-17
- Decision code
- OK30
- Date received
- 2019-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes to the current in-process inspections of the ATTUNE CR and ATTUNE PS Femoral Components at the DePuy Raynham, Massachusetts manufacturing site.