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.
The request to release the software version 1. 6. 2 in the united states, incorporating into the alinity m system software version 1. 6. 0, version 1. 6. 1 and 1. 6. 2, which are currently released outside the us, is approved.
| Device | Alinity m HBV |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Abbott Molecular, Inc. |
| Date Received | 2021-04-15 |
| Decision Date | 2021-06-01 |
| PMA | P200013 |
| Supplement | S005 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |