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 changes to the manufacturing and quality control testing for axsym ausab calibrators, controls, and reagents.
| Device | ABBOTT AXSYM AUSAB |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2010-06-11 |
| Decision Date | 2011-06-09 |
| PMA | P060003 |
| Supplement | S005 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road dept 9va- Ap5-2 abbott Park, IL 60064 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060003 | Original Filing | |
| S012 | 2012-11-13 | 30-day Notice |
| S011 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S010 | 2011-09-06 | 30-day Notice |
| S009 | 2011-03-21 | 135 Review Track For 30-day Notice |
| S008 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S007 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S006 | 2010-09-27 | 30-day Notice |
| S005 | 2010-06-11 | Real-time Process |
| S004 | 2009-02-17 | 30-day Notice |
| S003 | 2007-01-17 | 30-day Notice |
| S002 | 2006-09-05 | 30-day Notice |
| S001 | 2006-08-15 | 30-day Notice |