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 modifications to the labeling for the identified products. Specifically requested was the following: 1) an additional warning to address concerns related to the use of potential patients with a suspected malignancy; 2) an additional warning related to device migration; 3) a modification to the precaution related to ectopic, heterotopic and exuberant bone formation by removing the initial qualifying language: and 4) a modification to the description of the reconstituted recombinant protein solution, i. E. , "... Colorless to slightly yellow... "
| 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 | 2011-10-20 |
| Decision Date | 2012-07-17 |
| PMA | P000058 |
| Supplement | S048 |
| 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 |