PMA P060037S071
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S071
- Product code
- NJLÂ
- Decision date
- 2021-06-14
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- A Change To An External Process Challenge Device (PCD) Vial Diameter For Hydrogen Peroxide Gas Plasma Sterilization In Order To Adjust The Resistance Level Of The PCD To An Appropriate Level
Current openFDA PMA Record
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S071
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2021-06-14
- Decision code
- OK30
- Date received
- 2021-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to an external process challenge device (PCD) vial diameter for hydrogen peroxide gas plasma sterilization in order to adjust the resistance level of the PCD to an appropriate level.