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 replacement of bond-max slide staining assembly (ssa) printed wiring assembly (pwa) and bond software update from version 5. 1 to 6. 0.
| Device | BOND Oracle HER2 IHC System |
| Classification Name | System, Test, Her-2/neu, Ihc |
| Generic Name | System, Test, Her-2/neu, Ihc |
| Applicant | Leica Biosystems |
| Date Received | 2018-10-26 |
| Decision Date | 2019-01-23 |
| PMA | P090015 |
| Supplement | S006 |
| Product Code | MVC |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Leica Biosystems 36 Cherry Hill Drive danvers, MA 01923 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090015 | Original Filing | |
| S012 | 2020-08-28 | 30-day Notice |
| S011 | 2020-04-02 | 30-day Notice |
| S010 | 2019-12-13 | 30-day Notice |
| S009 | 2019-09-09 | 30-day Notice |
| S008 | 2019-07-24 | 30-day Notice |
| S007 | 2019-04-01 | 30-day Notice |
| S006 | 2018-10-26 | Real-time Process |
| S005 | 2017-06-27 | 30-day Notice |
| S004 | 2017-02-02 | 30-day Notice |
| S003 | 2015-04-20 | Special (immediate Track) |
| S002 | 2014-11-28 | Real-time Process |
| S001 | 2013-07-26 | Normal 180 Day Track |