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 the use of new manufacturing equipment used to preclean devices.
| Device | BIRMINGHAM HIP RESURFACING SYSTEM, REFLECTION CERAMIC ACETABULAR HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Applicant | SMITH&NEPHEW ORTHOPAEDICS |
| Date Received | 2009-07-22 |
| Decision Date | 2009-10-07 |
| PMA | P040033 |
| Supplement | S012 |
| Product Code | NXT |
| 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 ORTHOPAEDICS 7135 Goodlett Farms Parkway cordova, TN 38016 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040033 | Original Filing | |
| S036 | 2022-04-22 | 30-day Notice |
| S035 | ||
| S034 | ||
| S033 | 2018-01-31 | Special (immediate Track) |
| S032 | 2017-11-24 | 30-day Notice |
| S031 | 2017-01-17 | 135 Review Track For 30-day Notice |
| S030 | 2016-07-29 | Normal 180 Day Track No User Fee |
| S029 | 2015-12-28 | 30-day Notice |
| S028 | 2015-07-15 | Special (immediate Track) |
| S027 | 2014-05-22 | Real-time Process |
| S026 | 2014-05-20 | Special (immediate Track) |
| S025 | 2014-05-14 | Real-time Process |
| S024 | 2013-11-21 | Normal 180 Day Track No User Fee |
| S023 | 2013-06-06 | Real-time Process |
| S022 | ||
| S021 | 2011-06-28 | 30-day Notice |
| S020 | 2011-02-14 | Special (immediate Track) |
| S019 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S018 | 2010-12-28 | Normal 180 Day Track No User Fee |
| S017 | 2010-10-18 | 135 Review Track For 30-day Notice |
| S016 | 2010-09-14 | Special (immediate Track) |
| S015 | 2010-01-11 | Real-time Process |
| S014 | 2009-11-13 | Special (immediate Track) |
| S013 | 2009-07-22 | 135 Review Track For 30-day Notice |
| S012 | 2009-07-22 | 135 Review Track For 30-day Notice |
| S011 | 2009-04-17 | Real-time Process |
| S010 | 2008-12-17 | Real-time Process |
| S009 | 2008-11-28 | 30-day Notice |
| S008 | 2008-11-13 | Real-time Process |
| S007 | 2007-10-17 | 135 Review Track For 30-day Notice |
| S006 | 2007-04-10 | Normal 180 Day Track |
| S005 | 2007-04-02 | Real-time Process |
| S004 | 2007-03-12 | Normal 180 Day Track No User Fee |
| S003 | 2006-12-26 | Normal 180 Day Track No User Fee |
| S002 | 2006-11-20 | Normal 180 Day Track No User Fee |
| S001 | 2006-08-23 | Real-time Process |