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.
To add an additional incoming quality control (iqc) test for a reagent
| 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 | 2019-09-09 |
| Decision Date | 2019-10-25 |
| PMA | P090015 |
| Supplement | S009 |
| Product Code | MVC |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |