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 relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
| Device | AXSYM CORE 2.0 (LN 8B88) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2011-11-02 |
| Decision Date | 2011-12-22 |
| PMA | P060012 |
| Supplement | S009 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road ap5n-2, Dept. 09vb abbott Park, IL 60064 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060012 | Original Filing | |
| S010 | 2012-11-13 | 30-day Notice |
| S009 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S008 | 2011-09-07 | Special (immediate Track) |
| S007 | 2011-03-21 | 135 Review Track For 30-day Notice |
| S006 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S005 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S004 | 2010-09-27 | 30-day Notice |
| S003 | 2010-09-21 | 30-day Notice |
| S002 | 2010-05-19 | 30-day Notice |
| S001 | 2007-01-17 | 30-day Notice |