PMA P060037S072
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S072
- Product code
- NJLÂ
- Decision date
- 2021-07-19
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- Approval For Expanding The Packaging Cleanroom To Increase Capacity Within The Existing Zimmer Facility In Warsaw Indiana
Current openFDA PMA Record
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S072
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2021-07-19
- Decision code
- OK30
- Date received
- 2021-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expanding the packaging cleanroom to increase capacity within the existing Zimmer facility in Warsaw Indiana.