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.
Approval for addition of an alternate site for the machining processes for r3 acetabular shells.
| Device | REFLECTION CERAMIC HIP SYSTEM (RCHS) |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | Smith & Nephew, Inc. |
| Date Received | 2012-02-01 |
| Decision Date | 2012-06-28 |
| PMA | P030022 |
| Supplement | S021 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030022 | Original Filing | |
| S049 | 2022-07-14 | 30-day Notice |
| S048 | 2022-06-06 | 30-day Notice |
| S047 | 2022-05-23 | 30-day Notice |
| S046 | ||
| S045 | 2017-11-24 | 30-day Notice |
| S044 | 2017-07-19 | 30-day Notice |
| S043 | 2017-05-04 | 30-day Notice |
| S042 | 2016-12-19 | Special (immediate Track) |
| S041 | 2016-11-23 | Special (immediate Track) |
| S040 | 2016-10-17 | Special (immediate Track) |
| S039 | 2016-09-19 | Normal 180 Day Track No User Fee |
| S038 | 2016-07-15 | Normal 180 Day Track No User Fee |
| S037 | 2016-07-07 | Real-time Process |
| S036 | 2016-06-23 | Special (immediate Track) |
| S035 | 2015-12-28 | 30-day Notice |
| S034 | 2015-11-24 | 30-day Notice |
| S033 | 2015-07-27 | Normal 180 Day Track No User Fee |
| S032 | 2015-07-27 | Real-time Process |
| S031 | 2014-09-12 | 30-day Notice |
| S030 | 2014-05-02 | 30-day Notice |
| S029 | 2013-12-20 | 30-day Notice |
| S028 | 2013-12-18 | 30-day Notice |
| S027 | 2013-11-12 | 135 Review Track For 30-day Notice |
| S026 | 2013-09-25 | 30-day Notice |
| S025 | 2013-06-06 | Real-time Process |
| S024 | 2013-03-21 | 135 Review Track For 30-day Notice |
| S023 | 2013-02-19 | 135 Review Track For 30-day Notice |
| S022 | 2012-08-10 | 30-day Notice |
| S021 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S020 | 2011-12-21 | 30-day Notice |
| S019 | 2011-07-14 | 30-day Notice |
| S018 | 2011-04-29 | 30-day Notice |
| S017 | 2010-10-18 | 135 Review Track For 30-day Notice |
| S016 | 2010-07-07 | Real-time Process |
| S015 | 2010-07-02 | 135 Review Track For 30-day Notice |
| S014 | 2010-05-12 | 30-day Notice |
| S013 | 2009-08-12 | 30-day Notice |
| S012 | 2009-07-22 | 135 Review Track For 30-day Notice |
| S011 | 2008-11-28 | 30-day Notice |
| S010 | 2008-09-10 | Normal 180 Day Track No User Fee |
| S009 | 2008-02-06 | 135 Review Track For 30-day Notice |
| S008 | 2007-10-02 | Normal 180 Day Track |
| S007 | ||
| S006 | 2007-05-31 | 135 Review Track For 30-day Notice |
| S005 | 2007-05-01 | 135 Review Track For 30-day Notice |
| S004 | 2006-04-20 | 135 Review Track For 30-day Notice |
| S003 | 2006-04-20 | 135 Review Track For 30-day Notice |
| S002 | 2006-02-14 | 135 Review Track For 30-day Notice |
| S001 | 2005-09-02 | Real-time Process |