PMA P060037S056
- Device
- NexGen LPS-Flex/LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S056
- Product code
- NJL
- Decision date
- 2018-05-23
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Addition of IMR Laboratories, located at Lansing, New York, USA and Louisville, Kentucky, USA as approved suppliers to complete cleaning residual analysis for validations and process monitoring of the final cleaning process for the NexGen LPS-Flex/LPS-Mobile Bearing Knee System components manufactured in Warsaw, Indiana, USA and Shannon, Ireland facilities.
Current openFDA PMA Record#
- Device
- NexGen LPS-Flex/LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S056
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2018-05-23
- Decision code
- OK30
- Date received
- 2018-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of IMR Laboratories, located at Lansing, New York, USA and Louisville, Kentucky, USA as approved suppliers to complete cleaning residual analysis for validations and process monitoring of the final cleaning process for the NexGen LPS-Flex/LPS-Mobile Bearing Knee System components manufactured in Warsaw, Indiana, USA and Shannon, Ireland facilities.