PMA P060037S043
- Device
- ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S043
- Product code
- NJL
- Decision date
- 2016-01-15
- 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 THE ADDITION OF WARNINGS REGARDING USE OF THE DEVICE IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT.
Current openFDA PMA Record#
- Device
- ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S043
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2016-01-15
- Decision code
- APPR
- Date received
- 2015-12-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF WARNINGS REGARDING USE OF THE DEVICE IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT.