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 removal of ellman¿s assay and sds-page silver stain tests from the rhbmp-2 drug substance release specification.
| Device | INFUSE BONE GRAFT |
| Classification Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction |
| Generic Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2009-09-01 |
| Decision Date | 2010-01-14 |
| PMA | P000054 |
| Supplement | S023 |
| Product Code | MPW |
| 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 | Yes |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000054 | Original Filing | |
| S068 | 2022-07-21 | 30-day Notice |
| S067 | 2022-05-10 | 30-day Notice |
| S066 | 2022-01-20 | 30-day Notice |
| S065 | 2021-03-09 | 30-day Notice |
| S064 | 2021-01-15 | 30-day Notice |
| S063 | 2020-07-30 | 30-day Notice |
| S062 | ||
| S061 | ||
| S060 | ||
| S059 | 2020-06-11 | 30-day Notice |
| S058 | 2019-11-04 | 30-day Notice |
| S057 | 2019-10-31 | 30-day Notice |
| S056 | 2019-09-25 | 30-day Notice |
| S055 | ||
| S054 | ||
| S053 | 2019-06-28 | 30-day Notice |
| S052 | 2018-10-17 | Normal 180 Day Track |
| S051 | 2018-10-02 | 30-day Notice |
| S050 | 2018-08-02 | 30-day Notice |
| S049 | 2017-11-13 | 30-day Notice |
| S048 | 2017-05-23 | 30-day Notice |
| S047 | ||
| S046 | 2017-02-03 | 30-day Notice |
| S045 | 2017-01-23 | 30-day Notice |
| S044 | 2016-06-21 | Normal 180 Day Track |
| S043 | 2014-10-27 | Normal 180 Day Track No User Fee |
| S042 | 2014-01-27 | Normal 180 Day Track |
| S041 | ||
| S040 | 2013-10-25 | Real-time Process |
| S039 | 2013-03-07 | Special (immediate Track) |
| S038 | 2013-02-26 | 30-day Notice |
| S037 | 2013-01-14 | 30-day Notice |
| S036 | 2012-12-21 | 30-day Notice |
| S035 | 2012-08-21 | 135 Review Track For 30-day Notice |
| S034 | 2011-12-19 | Normal 180 Day Track |
| S033 | 2011-10-20 | Special (immediate Track) |
| S032 | 2011-10-04 | 135 Review Track For 30-day Notice |
| S031 | 2011-06-16 | 135 Review Track For 30-day Notice |
| S030 | 2011-02-15 | 135 Review Track For 30-day Notice |
| S029 | 2011-01-13 | 30-day Notice |
| S028 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S027 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S026 | 2010-09-01 | Normal 180 Day Track No User Fee |
| S025 | 2010-06-03 | 135 Review Track For 30-day Notice |
| S024 | 2010-02-24 | Special (immediate Track) |
| S023 | 2009-09-01 | 135 Review Track For 30-day Notice |
| S022 | 2009-03-25 | 135 Review Track For 30-day Notice |
| S021 | 2009-03-16 | Special (immediate Track) |
| S020 | 2008-12-23 | Real-time Process |
| S019 | 2008-11-21 | 135 Review Track For 30-day Notice |
| S018 | 2008-08-29 | 135 Review Track For 30-day Notice |
| S017 | 2008-01-14 | 135 Review Track For 30-day Notice |
| S016 | 2007-11-16 | Normal 180 Day Track No User Fee |
| S015 | 2007-11-06 | Normal 180 Day Track No User Fee |
| S014 | ||
| S013 | 2007-07-31 | 135 Review Track For 30-day Notice |
| S012 | ||
| S011 | 2007-04-06 | 135 Review Track For 30-day Notice |
| S010 | 2006-12-22 | 135 Review Track For 30-day Notice |
| S009 | 2006-10-27 | Normal 180 Day Track |
| S008 | 2006-10-12 | Special (immediate Track) |
| S007 | ||
| S006 | 2005-02-22 | Real-time Process |
| S005 | 2005-02-04 | 135 Review Track For 30-day Notice |
| S004 | 2005-01-26 | Real-time Process |
| S003 | 2004-09-17 | 135 Review Track For 30-day Notice |
| S002 | 2004-08-02 | Real-time Process |
| S001 | 2004-05-20 | Real-time Process |