PMA P060037S073
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- Product code
- NJL
- Decision date
- 2021-12-15
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Approval to modify the labeling to reflect the findings of the final Post-Approval Study (PAS) report.
Current openFDA PMA Record#
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S073
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2021-12-15
- Decision code
- APPR
- Date received
- 2021-06-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval to modify the labeling to reflect the findings of the final Post-Approval Study (PAS) report.