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 modification to the package insert. Specifically, adding the following additional events to the "possible adverse events" section of the insert: "edema (swelling), inflammation, erythematous, allergic reaction, dysphasia, itching, anaphylactic reaction, elevated erythrocyte sedimentation rate, pain, hematoma. "
| Device | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE |
| Classification Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction |
| Generic Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2004-03-04 |
| Decision Date | 2004-03-30 |
| PMA | P000058 |
| Supplement | S007 |
| Product Code | NEK |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000058 | Original Filing | |
| S087 | 2022-07-21 | 30-day Notice |
| S086 | 2022-05-10 | 30-day Notice |
| S085 | 2022-01-20 | 30-day Notice |
| S084 | 2021-03-09 | 30-day Notice |
| S083 | 2021-01-15 | 30-day Notice |
| S082 | 2020-07-30 | 30-day Notice |
| S081 | ||
| S080 | ||
| S079 | ||
| S078 | 2020-06-11 | 30-day Notice |
| S077 | 2019-11-04 | 30-day Notice |
| S076 | 2019-10-31 | 30-day Notice |
| S075 | 2019-09-25 | 30-day Notice |
| S074 | ||
| S073 | ||
| S072 | 2019-06-28 | 30-day Notice |
| S071 | 2018-10-17 | Normal 180 Day Track |
| S070 | 2018-10-02 | 30-day Notice |
| S069 | 2018-08-02 | 30-day Notice |
| S068 | 2017-11-13 | 30-day Notice |
| S067 | 2017-05-23 | 30-day Notice |
| S066 | ||
| S065 | 2017-04-28 | Normal 180 Day Track |
| S064 | 2017-02-03 | 30-day Notice |
| S063 | 2017-01-23 | 30-day Notice |
| S062 | 2016-08-31 | 30-day Notice |
| S061 | 2016-07-11 | 30-day Notice |
| S060 | 2016-06-21 | Normal 180 Day Track |
| S059 | 2015-04-13 | Normal 180 Day Track |
| S058 | 2014-10-29 | Real-time Process |
| S057 | 2014-10-27 | Normal 180 Day Track No User Fee |
| S056 | 2014-01-27 | Normal 180 Day Track |
| S055 | ||
| S054 | 2013-10-25 | Real-time Process |
| S053 | 2013-02-26 | 30-day Notice |
| S052 | 2013-01-14 | 30-day Notice |
| S051 | 2012-12-21 | 30-day Notice |
| S050 | 2012-08-21 | 135 Review Track For 30-day Notice |
| S049 | 2011-12-19 | Normal 180 Day Track |
| S048 | 2011-10-20 | Special (immediate Track) |
| S047 | 2011-10-04 | 135 Review Track For 30-day Notice |
| S046 | 2011-08-26 | Real-time Process |
| S045 | 2011-08-19 | Special (immediate Track) |
| S044 | 2011-06-16 | 135 Review Track For 30-day Notice |
| S043 | 2011-02-15 | 135 Review Track For 30-day Notice |
| S042 | 2011-01-13 | 30-day Notice |
| S041 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S040 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S039 | 2010-09-01 | Normal 180 Day Track No User Fee |
| S038 | 2010-06-03 | 135 Review Track For 30-day Notice |
| S037 | 2010-05-14 | Normal 180 Day Track No User Fee |
| S036 | 2010-02-24 | Special (immediate Track) |
| S035 | ||
| S034 | 2009-09-01 | 135 Review Track For 30-day Notice |
| S033 | 2009-03-25 | 135 Review Track For 30-day Notice |
| S032 | 2009-03-16 | Special (immediate Track) |
| S031 | 2008-12-23 | Real-time Process |
| S030 | 2008-11-21 | 135 Review Track For 30-day Notice |
| S029 | 2008-08-29 | 135 Review Track For 30-day Notice |
| S028 | 2008-01-14 | 135 Review Track For 30-day Notice |
| S027 | 2007-11-16 | Normal 180 Day Track No User Fee |
| S026 | 2007-11-06 | Normal 180 Day Track No User Fee |
| S025 | 2007-07-31 | 135 Review Track For 30-day Notice |
| S024 | ||
| S023 | 2007-04-06 | 135 Review Track For 30-day Notice |
| S022 | 2007-03-05 | Normal 180 Day Track |
| S021 | 2006-12-22 | 135 Review Track For 30-day Notice |
| S020 | 2006-10-27 | Normal 180 Day Track |
| S019 | 2006-10-12 | Special (immediate Track) |
| S018 | ||
| S017 | 2005-02-22 | Real-time Process |
| S016 | 2005-02-04 | 135 Review Track For 30-day Notice |
| S015 | 2004-11-15 | Real-time Process |
| S014 | 2004-09-17 | 135 Review Track For 30-day Notice |
| S013 | ||
| S012 | ||
| S011 | ||
| S010 | 2004-05-20 | Real-time Process |
| S009 | 2004-04-20 | Real-time Process |
| S008 | 2004-03-19 | Special (immediate Track) |
| S007 | 2004-03-04 | Special (immediate Track) |
| S006 | 2003-08-26 | Normal 180 Day Track No User Fee |
| S005 | 2003-08-22 | Normal 180 Day Track No User Fee |
| S004 | 2003-07-01 | Normal 180 Day Track |
| S003 | 2002-12-16 | Normal 180 Day Track |
| S002 | ||
| S001 |