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. |
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Device | ZIMMER NEXGEN LPS-FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEMS |
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 | S009 |
Date Received | 04/24/2009 |
Decision Date | 11/03/2010 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF PROLONG HIGHLY CROSSLINKED POLYETHYLENE TIBIAL ARTICULAR SURFACES TO THE NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM. |
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