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 kitting and storage location for infuse® bone graft and is indicated for treating acute, open tibial shaft fractures that have been stabilized with im nail fixation after appropriate wound management, an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets, and for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from l4-s1.
| 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 | 2009-03-25 |
| Decision Date | 2009-10-21 |
| PMA | P000054 |
| Supplement | S022 |
| 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 |