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.
Addition of alternative testing location for a device component
| Device | Alinity m HBV |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Abbott Molecular, Inc. |
| Date Received | 2021-02-05 |
| Decision Date | 2021-03-08 |
| PMA | P200013 |
| Supplement | S004 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Molecular, Inc. 1300 E Touhy Ave des Plaines, IL 60018 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200013 | Original Filing | |
| S012 | 2022-12-20 | 30-day Notice |
| S011 | 2022-12-07 | Special (immediate Track) |
| S010 | ||
| S009 | 2022-09-21 | Special (immediate Track) |
| S008 | 2022-05-10 | 30-day Notice |
| S007 | ||
| S006 | 2022-02-17 | 30-day Notice |
| S005 | 2021-04-15 | Real-time Process |
| S004 | 2021-02-05 | 30-day Notice |
| S003 | 2021-02-05 | 30-day Notice |
| S002 | ||
| S001 | 2020-12-21 | 30-day Notice |