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 change to the sterilization parameters that will be used for the bhr components from the previously approved dose range of 25-35 kgy to 25-50 kgy.
| Device | BIRMINGHAM HIP RESURFACING (BHR) SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Applicant | SMITH&NEPHEW ORTHOPAEDICS |
| Date Received | 2017-01-17 |
| Decision Date | 2018-02-22 |
| PMA | P040033 |
| Supplement | S031 |
| Product Code | NXT |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |