Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | NexGen LPS-Flex/LPS Mobile Bearing Knee System |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | ZIMMER, INC. P.O. Box 708 Warsaw, IN 46581-0708 |
PMA Number | P060037 |
Supplement Number | S067 |
Date Received | 09/17/2020 |
Decision Date | 09/24/2020 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replacement of the Prolong UHMWPE crosslinked material specification document, change in references of inspection methodology procedure from the firms internal document to ASTM standards, removal of Free Radical Level by Electron Spin Resonance requirement, and elimination of critical process parameters from the specification document as the ownership of the process is being transferred to a supplier and the supplier will be responsible to maintain these critical process parameters and process monitoring. |
|
|