FDA.reportPublic FDA data

PMA P060037S071

Device
NexGen LPS-Flex/LPS Mobile Bearing Knee System
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S071
Product code
NJL
Decision date
2021-06-14
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Change to an external process challenge device (PCD) vial diameter for hydrogen peroxide gas plasma sterilization in order to adjust the resistance level of the PCD to an appropriate level.

Current openFDA PMA Record#

Device
NexGen LPS-Flex/LPS Mobile Bearing Knee System
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S071
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2021-06-14
Decision code
OK30
Date received
2021-06-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to an external process challenge device (PCD) vial diameter for hydrogen peroxide gas plasma sterilization in order to adjust the resistance level of the PCD to an appropriate level.