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 extension of the rhbmp-2 drug substance expiration date from 60 to 72 months using the approved expiration date modification protocol. The device, as modified, will be marketed under the trade name infuse bone graft and is indicated for the following: 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 | 2013-10-25 |
| Decision Date | 2013-12-06 |
| PMA | P050053 |
| Supplement | S031 |
| Product Code | NPZ |
| Advisory Committee | Dental |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 1800 Pyramid Place memphis, TN 38132 |
| 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 |