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 | CERAMAX Ceramic Total Hip System |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS096 Date Received04/06/2022 Decision Date04/14/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-06 |
| Decision Date | 2022-04-14 |
| PMA | P070026 |
| Supplement | S096 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY ORTHOPAEDICS, INC. 700 Orthopaedic Drive warsaw, IN 46582 PMA NumberP070026 Supplement NumberS096 Date Received04/06/2022 Decision Date04/14/2022 Product Code MRA 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 Introduction Of A New Alternative Asset (i.e., A Dry Bag Press) Which Will Be Used In The Manufacturing Process For The Biolox Delta Ball Head Components Of The CERAMAX Ceramic Total Hip System |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070026 | Original Filing | |
| S103 | 2022-11-28 | 30-day Notice |
| S102 | 2022-09-07 | 30-day Notice |
| S101 | 2022-07-28 | 30-day Notice |
| S100 | 2022-07-01 | 30-day Notice |
| S099 | ||
| S098 | 2022-05-09 | 30-day Notice |
| S097 | 2022-04-07 | Special (immediate Track) |
| S096 | 2022-04-06 | 30-day Notice |
| S095 | ||
| S094 | 2022-02-22 | Special (immediate Track) |
| S093 | 2022-02-14 | 30-day Notice |
| S092 | ||
| S091 | 2022-02-11 | 30-day Notice |
| S090 | 2022-02-07 | 30-day Notice |
| S089 | 2021-12-27 | 30-day Notice |
| S088 | 2021-11-09 | Special (immediate Track) |
| S087 | 2021-11-01 | 30-day Notice |
| S086 | ||
| S085 | 2021-08-18 | 30-day Notice |
| S084 | 2021-07-21 | 30-day Notice |
| S083 | 2021-06-21 | 30-day Notice |
| S082 | 2021-06-09 | Special (immediate Track) |
| S081 | 2021-04-29 | 30-day Notice |
| S080 | 2021-04-26 | 30-day Notice |
| S079 | ||
| S078 | 2020-11-25 | 30-day Notice |
| S077 | 2020-11-06 | 30-day Notice |
| S076 | 2020-09-30 | 30-day Notice |
| S075 | 2020-06-23 | 30-day Notice |
| S074 | 2020-06-18 | 30-day Notice |
| S073 | ||
| S072 | 2020-05-29 | Normal 180 Day Track No User Fee |
| S071 | 2020-04-08 | 30-day Notice |
| S070 | ||
| S069 | 2019-10-30 | 30-day Notice |
| S068 | ||
| S067 | 2019-07-15 | Special (immediate Track) |
| S066 | ||
| S065 | 2019-07-02 | Normal 180 Day Track No User Fee |
| S064 | ||
| S063 | 2019-05-21 | Normal 180 Day Track No User Fee |
| S062 | ||
| S061 | ||
| S060 | 2019-04-19 | 30-day Notice |
| S059 | ||
| S058 | 2019-04-12 | 30-day Notice |
| S057 | 2019-03-27 | Special (immediate Track) |
| S056 | 2019-03-14 | 30-day Notice |
| S055 | 2018-07-27 | 30-day Notice |
| S054 | 2018-04-06 | 30-day Notice |
| S053 | 2018-04-05 | 30-day Notice |
| S052 | 2018-02-26 | 30-day Notice |
| S051 | 2018-01-31 | 30-day Notice |
| S050 | 2017-09-29 | Real-time Process |
| S049 | 2017-06-29 | 30-day Notice |
| S048 | 2017-06-23 | 30-day Notice |
| S047 | 2017-02-27 | 30-day Notice |
| S046 | 2017-02-16 | Real-time Process |
| S045 | 2017-01-27 | 30-day Notice |
| S044 | 2016-12-05 | 30-day Notice |
| S043 | 2016-10-31 | Special Supplement |
| S042 | 2016-08-10 | 30-day Notice |
| S041 | ||
| S040 | 2016-07-29 | Normal 180 Day Track No User Fee |
| S039 | 2016-07-19 | 30-day Notice |
| S038 | 2016-07-19 | 30-day Notice |
| S037 | 2016-06-13 | 30-day Notice |
| S036 | 2016-05-19 | 30-day Notice |
| S035 | 2016-04-22 | 30-day Notice |
| S034 | 2016-03-01 | 30-day Notice |
| S033 | 2015-12-01 | 30-day Notice |
| S032 | 2015-11-13 | 30-day Notice |
| S031 | 2015-07-24 | Normal 180 Day Track No User Fee |
| S030 | 2015-06-03 | 30-day Notice |
| S029 | 2015-03-03 | Special (immediate Track) |
| S028 | 2015-02-18 | 30-day Notice |
| S027 | ||
| S026 | 2014-10-14 | Normal 180 Day Track No User Fee |
| S025 | 2014-10-14 | Normal 180 Day Track No User Fee |
| S024 | 2014-10-14 | Normal 180 Day Track No User Fee |
| S023 | 2014-09-16 | 135 Review Track For 30-day Notice |
| S022 | 2014-04-30 | Normal 180 Day Track No User Fee |
| S021 | 2014-02-26 | Normal 180 Day Track No User Fee |
| S020 | 2013-09-12 | Real-time Process |
| S019 | 2013-08-26 | Real-time Process |
| S018 | 2013-08-01 | Real-time Process |
| S017 | 2013-06-27 | Normal 180 Day Track No User Fee |
| S016 | 2013-06-27 | Normal 180 Day Track No User Fee |
| S015 | ||
| S014 | 2013-05-03 | Normal 180 Day Track No User Fee |
| S013 | 2013-04-11 | Special (immediate Track) |
| S012 | 2013-03-12 | 135 Review Track For 30-day Notice |
| S011 | 2012-10-31 | Normal 180 Day Track No User Fee |
| S010 | 2012-10-25 | 30-day Notice |
| S009 | 2012-09-28 | Real-time Process |
| S008 | 2012-09-28 | Real-time Process |
| S007 | 2012-08-03 | Special (immediate Track) |
| S006 | 2012-05-18 | 30-day Notice |
| S005 | 2012-03-27 | 30-day Notice |
| S004 | 2011-11-01 | Panel Track |
| S003 | 2011-07-18 | Real-time Process |
| S002 | ||
| S001 | 2011-04-08 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 10603295457411 | P070026 | 046 |
| 10603295457190 | P070026 | 046 |
| 10603295457206 | P070026 | 046 |
| 10603295457213 | P070026 | 046 |
| 10603295457220 | P070026 | 046 |
| 10603295457237 | P070026 | 046 |
| 10603295457244 | P070026 | 046 |
| 10603295457251 | P070026 | 046 |
| 10603295457268 | P070026 | 046 |
| 10603295457275 | P070026 | 046 |
| 10603295457282 | P070026 | 046 |
| 10603295457169 | P070026 | 046 |