PMA P060037S070
- Device
- NexGen LPS-Flex/LPS-Mobile Bearing Knee
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S070
- Product code
- NJLÂ
- Decision date
- 2020-12-17
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- Case For Quality Modified 30-Day Notice For The Addition Of The Validated In-house Testing System At The ZOML Shannon Microbiology Laboratory For The Completion Of Bacterial Endotoxin, Total Viable Count Testing And TOC And Conductivity Testing Of ZOML Shannon Water Samples. Also, The Firm Proposed The Addition Of Microbiological Laboratories At The Zimmer GmbH Facility In Winterthur, Switzerland Site And An External Contractor Accugenix For Testing Of All ZOML Shannon Microbial Samples Requiring Species/genus Level Identification Testing.
Current openFDA PMA Record
- Device
- NexGen LPS-Flex/LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S070
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-12-17
- Decision code
- OK30
- Date received
- 2020-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Case for Quality Modified 30-Day Notice for the addition of the validated in-house testing system at the ZOML Shannon microbiology laboratory for the completion of Bacterial Endotoxin, Total Viable Count testing and TOC and conductivity testing of ZOML Shannon water samples. Also, the Firm proposed the addition of microbiological laboratories at the Zimmer GmbH facility in Winterthur, Switzerland site and an external contractor Accugenix for testing of all ZOML Shannon microbial samples requiring species/genus level identification testing.