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 | NEXGEM LPS-FLEX MOBILE AND LPS-MOBILE KNEES |
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 | S020 |
Date Received | 09/27/2012 |
Decision Date | 03/28/2013 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | 135 review track for 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO AUTOMATE THE IN-PROCESS DYE PENETRANT TEST. |
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