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 | Oxford Partial Knee System |
Generic Name | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing |
Applicant | BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS101 Date Received03/11/2022 Decision Date04/04/2022 Product Code NRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-03-11 |
Decision Date | 2022-04-04 |
PMA | P010014 |
Supplement | S101 |
Product Code | NRA |
Advisory Committee | Orthopedic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | BIOMET MANUFACTURING CORP. 56 East Bell Drive p.o. Box 587 warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS101 Date Received03/11/2022 Decision Date04/04/2022 Product Code NRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement The Following PET/AlOx/LLDPE Packaging Pouch Related Changes: 1) New 2nd Tier Supplier For The Layer Lamination Process, 2) Alternate Adhesive Material Used In Lamination Process, 3) Relocation Of PET/AlOx Production, And 4) Alternate Supplier Of LLDPE Sealant Layer Material |
Supplement Number | Date | Supplement Type |
---|---|---|
P010014 | Original Filing | |
S103 | 2022-09-29 | 30-day Notice |
S102 | 2022-06-14 | Special (immediate Track) |
S101 | 2022-03-11 | 30-day Notice |
S100 | 2020-10-16 | Normal 180 Day Track No User Fee |
S099 | ||
S098 | ||
S097 | 2019-12-03 | 135 Review Track For 30-day Notice |
S096 | 2019-10-09 | Special (immediate Track) |
S095 | ||
S094 | 2019-09-11 | 30-day Notice |
S093 | 2019-08-29 | 30-day Notice |
S092 | 2019-08-19 | 30-day Notice |
S091 | 2019-08-12 | 30-day Notice |
S090 | 2019-07-11 | 30-day Notice |
S089 | 2019-04-26 | Real-time Process |
S088 | 2019-04-15 | 30-day Notice |
S087 | 2019-04-15 | Special (immediate Track) |
S086 | 2019-04-03 | 30-day Notice |
S085 | 2019-03-18 | 30-day Notice |
S084 | 2019-01-17 | Real-time Process |
S083 | 2018-11-20 | 30-day Notice |
S082 | 2018-09-25 | 30-day Notice |
S081 | 2018-07-03 | 135 Review Track For 30-day Notice |
S080 | 2018-06-28 | 30-day Notice |
S079 | 2018-06-19 | 30-day Notice |
S078 | ||
S077 | 2018-04-27 | 30-day Notice |
S076 | 2018-04-27 | 135 Review Track For 30-day Notice |
S075 | 2018-04-04 | 30-day Notice |
S074 | 2018-03-22 | Special (immediate Track) |
S073 | 2018-03-20 | 30-day Notice |
S072 | 2018-03-14 | 30-day Notice |
S071 | 2018-03-05 | Real-time Process |
S070 | 2018-02-15 | Special (immediate Track) |
S069 | 2018-01-24 | 30-day Notice |
S068 | 2017-11-16 | Special (immediate Track) |
S067 | 2017-09-11 | 30-day Notice |
S066 | 2017-09-06 | 30-day Notice |
S065 | 2017-08-15 | Special (immediate Track) |
S064 | ||
S063 | 2017-06-09 | Special (immediate Track) |
S062 | 2017-05-05 | 30-day Notice |
S061 | 2017-02-17 | 30-day Notice |
S060 | 2017-01-30 | 30-day Notice |
S059 | 2016-10-18 | Special (immediate Track) |
S058 | 2016-10-11 | Special (immediate Track) |
S057 | 2016-09-22 | 30-day Notice |
S056 | 2016-09-21 | Special (immediate Track) |
S055 | 2016-08-05 | Special (immediate Track) |
S054 | 2016-03-28 | 30-day Notice |
S053 | 2015-10-07 | 30-day Notice |
S052 | 2015-10-02 | Special (immediate Track) |
S051 | 2015-04-06 | Special (immediate Track) |
S050 | 2015-01-20 | 30-day Notice |
S049 | 2014-10-14 | 30-day Notice |
S048 | 2014-05-30 | Special (immediate Track) |
S047 | 2013-11-18 | 30-day Notice |
S046 | 2013-09-20 | 30-day Notice |
S045 | 2013-07-22 | Special (immediate Track) |
S044 | 2013-07-12 | Special (immediate Track) |
S043 | 2013-04-22 | Normal 180 Day Track No User Fee |
S042 | 2013-03-27 | Special (immediate Track) |
S041 | 2013-01-03 | Normal 180 Day Track No User Fee |
S040 | 2012-11-23 | 30-day Notice |
S039 | 2012-11-05 | 135 Review Track For 30-day Notice |
S038 | ||
S037 | 2012-07-16 | 30-day Notice |
S036 | 2012-07-02 | Special (immediate Track) |
S035 | 2012-06-25 | Special (immediate Track) |
S034 | ||
S033 | 2012-01-05 | Special (immediate Track) |
S032 | 2011-06-29 | 30-day Notice |
S031 | 2011-05-31 | Real-time Process |
S030 | 2011-02-22 | 30-day Notice |
S029 | 2010-10-26 | 135 Review Track For 30-day Notice |
S028 | 2010-11-09 | Real-time Process |
S027 | 2010-07-02 | Normal 180 Day Track No User Fee |
S026 | 2009-12-29 | Real-time Process |
S025 | ||
S024 | 2009-09-10 | 135 Review Track For 30-day Notice |
S023 | ||
S022 | 2008-10-24 | Special (immediate Track) |
S021 | 2008-06-18 | Real-time Process |
S020 | 2008-06-11 | 135 Review Track For 30-day Notice |
S019 | ||
S018 | 2007-11-20 | 135 Review Track For 30-day Notice |
S017 | 2007-08-22 | Real-time Process |
S016 | 2007-08-10 | Special (immediate Track) |
S015 | 2007-02-27 | 135 Review Track For 30-day Notice |
S014 | 2006-12-26 | Normal 180 Day Track No User Fee |
S013 | ||
S012 | 2006-11-16 | 135 Review Track For 30-day Notice |
S011 | 2006-11-15 | 30-day Notice |
S010 | ||
S009 | 2006-07-03 | Special (immediate Track) |
S008 | 2006-02-09 | Real-time Process |
S007 | ||
S006 | 2005-11-02 | 135 Review Track For 30-day Notice |
S005 | 2005-11-01 | Normal 180 Day Track No User Fee |
S004 | 2005-11-01 | 135 Review Track For 30-day Notice |
S003 | 2005-10-28 | 135 Review Track For 30-day Notice |
S002 | 2005-04-26 | Real-time Process |
S001 | 2004-06-04 | Normal 180 Day Track No User Fee |