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 FREE PSA (LN 3C20) |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | Abbott Laboratories |
| Date Received | 2011-11-02 |
| Decision Date | 2011-12-22 |
| PMA | P980007 |
| Supplement | S023 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| 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 100 Abbott Park Rd. ap5n-2 Dept 09vb abbott Park, IL 60064-6070 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980007 | Original Filing | |
| S048 | 2023-01-06 | 30-day Notice |
| S047 | 2022-09-14 | 30-day Notice |
| S046 | 2021-11-18 | 30-day Notice |
| S045 | 2021-11-09 | 30-day Notice |
| S044 | 2021-02-09 | Real-time Process |
| S043 | 2020-10-16 | 30-day Notice |
| S042 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S041 | ||
| S040 | 2015-07-16 | 30-day Notice |
| S039 | 2015-02-24 | 30-day Notice |
| S038 | 2014-11-14 | 30-day Notice |
| S037 | 2014-11-13 | 30-day Notice |
| S036 | 2014-06-02 | 30-day Notice |
| S035 | 2014-04-18 | 30-day Notice |
| S034 | 2014-04-16 | 30-day Notice |
| S033 | 2014-01-08 | 30-day Notice |
| S032 | 2013-10-30 | 30-day Notice |
| S031 | 2013-10-28 | 30-day Notice |
| S030 | 2013-02-11 | 30-day Notice |
| S029 | 2012-11-19 | 30-day Notice |
| S028 | 2012-11-15 | 30-day Notice |
| S027 | 2012-11-13 | 30-day Notice |
| S026 | 2012-07-03 | 30-day Notice |
| S025 | 2012-03-06 | 30-day Notice |
| S024 | 2011-11-23 | Special (immediate Track) |
| S023 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S022 | 2011-09-07 | Special (immediate Track) |
| S021 | 2011-05-25 | 30-day Notice |
| S020 | 2011-05-04 | Normal 180 Day Track No User Fee |
| S019 | 2011-04-18 | 30-day Notice |
| S018 | 2011-02-18 | 30-day Notice |
| S017 | 2011-02-17 | Normal 180 Day Track No User Fee |
| S016 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S015 | 2010-12-22 | Special (immediate Track) |
| S014 | ||
| S013 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S012 | 2010-09-27 | 30-day Notice |
| S011 | 2010-08-09 | Normal 180 Day Track No User Fee |
| S010 | 2010-04-02 | Real-time Process |
| S009 | 2008-05-21 | Normal 180 Day Track |
| S008 | 2007-01-17 | 30-day Notice |
| S007 | ||
| S006 | 2004-08-30 | 30-day Notice |
| S005 | 2004-08-05 | Real-time Process |
| S004 | 2004-04-01 | Real-time Process |
| S003 | 2003-01-31 | Normal 180 Day Track |
| S002 | 2002-02-01 | Normal 180 Day Track |
| S001 | 2001-06-15 | Normal 180 Day Track |