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 |
| Generic Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
| Applicant | ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS080 Date Received07/25/2022 Decision Date08/15/2022 Product Code NJL Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-08-15 |
| PMA | P060037 |
| Supplement | S080 |
| Product Code | NJL |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS080 Date Received07/25/2022 Decision Date08/15/2022 Product Code NJL Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Revising Device Labeling, Specifically Package Inserts, To Implement The Following Changes: Removal Of Re-sterilization Information, Addition Of Caution Information For Metal Sensitivity And Product Cleanliness, Addition Of Contact Information For Product Compatibility Questions, Disclosure Of Residual Risks With Products, And Addition Of Product Disposal Information |
| 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 |