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.
| Device | EBI OsteoGen™ Implantable Bone Growth Stimulators |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP790005 Supplement NumberS068 Date Received05/27/2022 Decision Date08/25/2022 Product Code LOE Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-27 |
| Decision Date | 2022-08-25 |
| PMA | P790005 |
| Supplement | S068 |
| Product Code | LOE |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 1 Gatehall Drive suite 303 parsippany, NJ 07054 PMA NumberP790005 Supplement NumberS068 Date Received05/27/2022 Decision Date08/25/2022 Product Code LOE Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Executing An Ethylene Oxide Terminal Sterilization Process Validation To Align With Applicable Requirements Of ISO 11135:2014 (14-529). |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790005 | Original Filing | |
| S069 | 2022-10-28 | 30-day Notice |
| S068 | 2022-05-27 | Real-time Process |
| S067 | 2021-01-21 | 30-day Notice |
| S066 | 2019-06-21 | 30-day Notice |
| S065 | ||
| S064 | 2018-04-09 | 30-day Notice |
| S063 | 2018-04-04 | 30-day Notice |
| S062 | 2018-04-02 | 135 Review Track For 30-day Notice |
| S061 | 2018-03-29 | 30-day Notice |
| S060 | 2018-03-09 | 30-day Notice |
| S059 | 2018-03-01 | 30-day Notice |
| S058 | 2018-02-21 | 30-day Notice |
| S057 | 2018-02-13 | 30-day Notice |
| S056 | 2017-05-04 | 30-day Notice |
| S055 | 2017-03-14 | 30-day Notice |
| S054 | 2015-12-17 | 30-day Notice |
| S053 | 2015-11-19 | 30-day Notice |
| S052 | 2015-10-08 | 30-day Notice |
| S051 | 2014-08-20 | 30-day Notice |
| S050 | 2013-09-06 | 30-day Notice |
| S049 | 2013-04-30 | 30-day Notice |
| S048 | 2011-12-21 | 30-day Notice |
| S047 | 2011-04-08 | Special (immediate Track) |
| S046 | ||
| S045 | 2008-07-17 | 30-day Notice |
| S044 | 2004-06-09 | Normal 180 Day Track |
| S043 | 2000-05-30 | Real-time Process |
| S042 | 2000-04-11 | Real-time Process |
| S041 | 1998-06-24 | Real-time Process |
| S040 | 1998-04-09 | Real-time Process |
| S039 | 1996-10-17 | Normal 180 Day Track |
| S038 | 1996-03-13 | Normal 180 Day Track |
| S037 | 1994-11-15 | Normal 180 Day Track |
| S036 | ||
| S035 | 1990-08-27 | Normal 180 Day Track |
| S034 | 1990-01-26 | Normal 180 Day Track |
| S033 | 1989-03-22 | Normal 180 Day Track |
| S032 | 1988-03-16 | Normal 180 Day Track |
| S031 | 1988-02-26 | Normal 180 Day Track |
| S030 | 1987-06-10 | Normal 180 Day Track |
| S029 | 1986-11-07 | Normal 180 Day Track |
| S028 | 1985-10-30 | |
| S027 | 1985-09-06 | |
| S026 | 1985-06-13 | |
| S025 | 1983-11-28 | |
| S024 | 1983-10-04 | |
| S023 | 1983-09-21 | |
| S022 | 1983-08-31 | |
| S021 | 1983-07-20 | |
| S020 | ||
| S019 | ||
| S018 | ||
| S017 | ||
| S016 | 1983-03-07 | |
| S015 | ||
| S014 | ||
| S013 | 1982-04-13 | |
| S012 | 1982-03-08 | |
| S011 | 1982-03-03 | |
| S010 | 1981-09-24 | |
| S009 | 1981-07-29 | |
| S008 | ||
| S007 | 1981-05-22 | |
| S006 | 1981-04-06 | |
| S005 | ||
| S004 | 1980-12-16 | Normal 180 Day Track |
| S003 | 1980-10-27 | |
| S002 | ||
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00812301020065 | P790005 | 032 |
| 00812301020119 | P790005 | 045 |
| 00812301020102 | P790005 | 045 |
| 00812301020072 | P790005 | 045 |
| 00812301020058 | P790005 | 045 |
| 00812301020041 | P790005 | 045 |
| 00812301020034 | P790005 | 045 |
| 00812301020027 | P790005 | 045 |
| 00812301020010 | P790005 | 045 |