PMA P060037S031
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S031
- Product code
- NJL
- Decision date
- 2015-07-02
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- APPROVAL FOR CHANGE IN STORAGE CONDITIONS, AND A CHANGE IN SHELF LIFE OF POLYETHYLENE BAR STOCK.
Current openFDA PMA Record#
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S031
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2015-07-02
- Decision code
- APPR
- Date received
- 2014-08-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGE IN STORAGE CONDITIONS, AND A CHANGE IN SHELF LIFE OF POLYETHYLENE BAR STOCK.