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.
A process change to eliminate a cytotoxicity test requirement for the monitoring of the final cleaning process.
Device | NexGen LPS-Flex/LPS-Mobile Bearing Knee System |
Classification Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
Generic Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
Applicant | ZIMMER, INC. |
Date Received | 2019-06-03 |
Decision Date | 2019-07-03 |
PMA | P060037 |
Supplement | S060 |
Product Code | NJL |
Advisory Committee | Orthopedic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708 |
Supplement Number | Date | Supplement Type |
---|---|---|
P060037 | Original Filing | |
S082 | 2022-09-30 | 30-day Notice |
S081 | ||
S080 | 2022-07-25 | Special (immediate Track) |
S079 | 2022-05-09 | 30-day Notice |
S078 | 2022-03-07 | 30-day Notice |
S077 | 2022-01-31 | 30-day Notice |
S076 | 2021-12-10 | 30-day Notice |
S075 | 2021-09-30 | 30-day Notice |
S074 | 2021-08-10 | 30-day Notice |
S073 | ||
S072 | 2021-06-21 | 30-day Notice |
S071 | 2021-06-10 | 30-day Notice |
S070 | 2020-11-25 | 30-day Notice |
S069 | 2020-09-28 | Real-time Process |
S068 | 2020-09-21 | 30-day Notice |
S067 | 2020-09-17 | 30-day Notice |
S066 | 2020-07-28 | 30-day Notice |
S065 | 2020-06-16 | 30-day Notice |
S064 | 2020-05-07 | 30-day Notice |
S063 | ||
S062 | 2019-09-26 | 30-day Notice |
S061 | 2019-07-11 | 30-day Notice |
S060 | 2019-06-03 | 30-day Notice |
S059 | ||
S058 | ||
S057 | 2018-11-07 | 30-day Notice |
S056 | 2018-04-23 | 30-day Notice |
S055 | 2018-02-27 | 30-day Notice |
S054 | 2018-02-20 | 30-day Notice |
S053 | 2017-10-19 | 30-day Notice |
S052 | 2017-09-29 | 30-day Notice |
S051 | 2017-09-07 | 30-day Notice |
S050 | 2017-08-31 | 30-day Notice |
S049 | 2017-06-07 | 30-day Notice |
S048 | 2016-11-23 | 30-day Notice |
S047 | 2016-09-08 | Normal 180 Day Track No User Fee |
S046 | 2016-08-08 | 30-day Notice |
S045 | 2016-05-03 | 30-day Notice |
S044 | 2016-03-31 | 30-day Notice |
S043 | 2015-12-17 | Special (immediate Track) |
S042 | 2015-10-30 | 30-day Notice |
S041 | 2015-10-16 | 30-day Notice |
S040 | 2015-09-30 | 30-day Notice |
S039 | 2015-08-12 | 30-day Notice |
S038 | 2015-06-29 | 135 Review Track For 30-day Notice |
S037 | 2015-06-26 | 30-day Notice |
S036 | 2015-06-22 | Special (immediate Track) |
S035 | 2015-03-17 | 30-day Notice |
S034 | 2015-02-24 | 30-day Notice |
S033 | 2014-12-04 | 30-day Notice |
S032 | 2014-09-30 | 135 Review Track For 30-day Notice |
S031 | 2014-08-28 | 135 Review Track For 30-day Notice |
S030 | 2014-02-18 | Normal 180 Day Track No User Fee |
S029 | 2014-01-22 | 30-day Notice |
S028 | 2013-09-30 | 135 Review Track For 30-day Notice |
S027 | 2013-09-23 | 135 Review Track For 30-day Notice |
S026 | 2013-08-08 | Normal 180 Day Track No User Fee |
S025 | ||
S024 | 2013-07-15 | 135 Review Track For 30-day Notice |
S023 | 2013-07-01 | 30-day Notice |
S022 | 2013-05-23 | 30-day Notice |
S021 | 2013-03-25 | 135 Review Track For 30-day Notice |
S020 | 2012-09-27 | 135 Review Track For 30-day Notice |
S019 | 2012-08-21 | 135 Review Track For 30-day Notice |
S018 | 2012-07-13 | 30-day Notice |
S017 | 2012-04-06 | 135 Review Track For 30-day Notice |
S016 | 2012-01-12 | 30-day Notice |
S015 | 2011-11-23 | 30-day Notice |
S014 | 2011-07-05 | 135 Review Track For 30-day Notice |
S013 | 2010-05-12 | Special (immediate Track) |
S012 | 2010-04-06 | Normal 180 Day Track No User Fee |
S011 | 2009-06-10 | 30-day Notice |
S010 | 2009-05-22 | Special (immediate Track) |
S009 | 2009-04-24 | Normal 180 Day Track |
S008 | 2009-04-21 | 30-day Notice |
S007 | 2008-11-25 | Real-time Process |
S006 | 2008-10-10 | 135 Review Track For 30-day Notice |
S005 | 2008-09-29 | Normal 180 Day Track |
S004 | 2008-09-02 | Normal 180 Day Track No User Fee |
S003 | 2008-06-06 | 135 Review Track For 30-day Notice |
S002 | ||
S001 | 2008-01-29 | 30-day Notice |