This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the infuse bone graft. The device is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.
| Device | INFUSE BONE GRAFT |
| Classification Name | Bone Grafting Material, Dental, With Biologic Component |
| Generic Name | Bone Grafting Material, Dental, With Biologic Component |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2005-12-30 |
| Decision Date | 2007-03-09 |
| Notice Date | 2007-03-13 |
| PMA | P050053 |
| Supplement | S |
| Product Code | NPZ |
| Docket Number | 07M-0084 |
| Advisory Committee | Dental |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 1800 Pyramid Place memphis, TN 38132 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050053 | Original Filing | |
| S059 | 2022-07-21 | 30-day Notice |
| S058 | 2022-05-10 | 30-day Notice |
| S057 | 2022-01-20 | 30-day Notice |
| S056 | 2021-03-09 | 30-day Notice |
| S055 | 2021-01-15 | 30-day Notice |
| S054 | 2020-07-30 | 30-day Notice |
| S053 | ||
| S052 | ||
| S051 | ||
| S050 | 2020-06-11 | 30-day Notice |
| S049 | 2019-11-04 | 30-day Notice |
| S048 | 2019-10-31 | 30-day Notice |
| S047 | 2019-09-25 | 30-day Notice |
| S046 | ||
| S045 | ||
| S044 | 2019-06-28 | 30-day Notice |
| S043 | 2018-10-17 | Normal 180 Day Track |
| S042 | 2018-10-02 | 30-day Notice |
| S041 | 2018-08-02 | 30-day Notice |
| S040 | 2017-11-13 | 30-day Notice |
| S039 | 2017-05-23 | 30-day Notice |
| S038 | ||
| S037 | 2017-02-03 | 30-day Notice |
| S036 | 2017-01-23 | 30-day Notice |
| S035 | 2016-06-21 | Normal 180 Day Track |
| S034 | 2014-10-27 | Normal 180 Day Track No User Fee |
| S033 | 2014-01-27 | Normal 180 Day Track |
| S032 | ||
| S031 | 2013-10-25 | Real-time Process |
| S030 | 2013-02-26 | 30-day Notice |
| S029 | 2013-01-14 | 30-day Notice |
| S028 | 2012-12-21 | 30-day Notice |
| S027 | ||
| S026 | 2012-08-21 | 135 Review Track For 30-day Notice |
| S025 | 2012-05-16 | Special (immediate Track) |
| S024 | 2011-12-19 | Normal 180 Day Track |
| S023 | 2011-10-04 | 135 Review Track For 30-day Notice |
| S022 | 2011-06-16 | 135 Review Track For 30-day Notice |
| S021 | 2011-02-15 | 135 Review Track For 30-day Notice |
| S020 | 2011-01-13 | 30-day Notice |
| S019 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S018 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S017 | 2010-09-01 | Normal 180 Day Track No User Fee |
| S016 | 2010-06-03 | 135 Review Track For 30-day Notice |
| S015 | 2010-05-14 | Normal 180 Day Track No User Fee |
| S014 | ||
| S013 | 2009-09-01 | 135 Review Track For 30-day Notice |
| S012 | 2009-03-25 | 135 Review Track For 30-day Notice |
| S011 | 2008-12-23 | Real-time Process |
| S010 | 2008-11-21 | 135 Review Track For 30-day Notice |
| S009 | 2008-08-29 | 135 Review Track For 30-day Notice |
| S008 | 2008-02-19 | Normal 180 Day Track |
| S007 | 2008-01-18 | 30-day Notice |
| S006 | 2008-01-14 | 135 Review Track For 30-day Notice |
| S005 | 2007-11-06 | Normal 180 Day Track No User Fee |
| S004 | 2007-07-31 | 135 Review Track For 30-day Notice |
| S003 | ||
| S002 | 2007-04-06 | 135 Review Track For 30-day Notice |
| S001 | 2007-03-19 | Normal 180 Day Track |