PMA P060037S066
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S066
- Product code
- NJL
- Decision date
- 2020-08-03
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Change of a Biological Indicator (BI) for hydrogen peroxide gas plasma sterilization.
Current openFDA PMA Record#
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S066
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-08-03
- Decision code
- OK30
- Date received
- 2020-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of a Biological Indicator (BI) for hydrogen peroxide gas plasma sterilization.