PMA P060037S067
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S067
- Product code
- NJLÂ
- Decision date
- 2020-09-24
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- Replacement Of The Prolong UHMWPE Crosslinked Material Specification Document, Change In References Of Inspection Methodology Procedure From The Firm's Internal Document To ASTM Standards, Removal Of "Free Radical Level By Electron Spin Resonance" Requirement, And Elimination Of Critical Process Parameters From The Specification Document As The Ownership Of The Process Is Being Transferred To A Supplier And The Supplier Will Be Responsible To Maintain These Critical Process Parameters And Process Monitoring
Current openFDA PMA Record
- Device
- NexGen LPS-Flex/LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S067
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-09-24
- Decision code
- OK30
- Date received
- 2020-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the Prolong UHMWPE crosslinked material specification document, change in references of inspection methodology procedure from the firms internal document to ASTM standards, removal of Free Radical Level by Electron Spin Resonance requirement, and elimination of critical process parameters from the specification document as the ownership of the process is being transferred to a supplier and the supplier will be responsible to maintain these critical process parameters and process monitoring.