PMA P060037S018
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S018
- Product code
- NJL
- Decision date
- 2012-08-10
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- CHANGE IN PACKAGE HEAT SEALING PROCESS PARAMETERS FOR THE INNER POUCH.
Current openFDA PMA Record#
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S018
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2012-08-10
- Decision code
- OK30
- Date received
- 2012-07-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN PACKAGE HEAT SEALING PROCESS PARAMETERS FOR THE INNER POUCH.