PMA P830055S229
- Device
- LCS Total Knee System - ATTUNE Revision Femoral and Tibial Sleeves
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S229
- Product code
- NJL
- Decision date
- 2019-05-10
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Changes to the current processing of the ATTUNE Revision Femoral and Tibial Sleeves at the DePuy Warsaw, Indiana manufacturing site.
Current openFDA PMA Record#
- Device
- LCS Total Knee System - ATTUNE Revision Femoral and Tibial Sleeves
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S229
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-05-10
- Decision code
- OK30
- Date received
- 2019-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the current processing of the ATTUNE Revision Femoral and Tibial Sleeves at the DePuy Warsaw, Indiana manufacturing site.