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 a labeling change for the reflection ceramic acetabular hip system which also includes the r3 ceramic acetabular hip system.
| Device | REFLECTION CERAMIC ACETABULAR HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | Smith & Nephew, Inc. |
| Date Received | 2016-06-23 |
| Decision Date | 2016-07-22 |
| PMA | P030022 |
| Supplement | S036 |
| Product Code | MRA |
| 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 | 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 |