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.
Change to convert the microparticle coating process from the automated microparticle processing system (amps) to the magnetic separation (magsep) process.
| Device | Axsym Total PSA & Architect Total PSA |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | Abbott Laboratories |
| Date Received | 2017-03-01 |
| Decision Date | 2017-03-28 |
| PMA | P910007 |
| Supplement | S050 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | 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. abbott Park, IL 60064-3500 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910007 | Original Filing | |
| S059 | 2023-01-06 | 30-day Notice |
| S058 | 2022-09-14 | 30-day Notice |
| S057 | 2021-11-18 | 30-day Notice |
| S056 | 2021-11-09 | 30-day Notice |
| S055 | 2021-02-09 | Real-time Process |
| S054 | 2020-10-16 | 30-day Notice |
| S053 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S052 | 2019-01-22 | Real-time Process |
| S051 | ||
| S050 | 2017-03-01 | 30-day Notice |
| S049 | 2015-07-16 | 30-day Notice |
| S048 | 2015-02-24 | 30-day Notice |
| S047 | 2014-11-14 | 30-day Notice |
| S046 | 2014-11-13 | 30-day Notice |
| S045 | 2014-06-02 | 30-day Notice |
| S044 | 2014-05-01 | 30-day Notice |
| S043 | 2014-04-16 | 30-day Notice |
| S042 | 2014-01-08 | 30-day Notice |
| S041 | 2013-10-30 | 30-day Notice |
| S040 | 2013-10-28 | 30-day Notice |
| S039 | 2013-02-11 | 30-day Notice |
| S038 | 2012-11-19 | 30-day Notice |
| S037 | 2012-11-15 | 30-day Notice |
| S036 | 2012-11-13 | 30-day Notice |
| S035 | 2012-08-03 | 30-day Notice |
| S034 | 2012-03-06 | 30-day Notice |
| S033 | 2011-11-23 | Special (immediate Track) |
| S032 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S031 | 2011-09-07 | Special (immediate Track) |
| S030 | 2011-05-25 | 30-day Notice |
| S029 | 2011-05-04 | Normal 180 Day Track No User Fee |
| S028 | 2011-04-18 | 30-day Notice |
| S027 | 2011-02-18 | 30-day Notice |
| S026 | 2011-02-17 | Normal 180 Day Track No User Fee |
| S025 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S024 | 2010-12-22 | Special (immediate Track) |
| S023 | 2010-11-22 | Normal 180 Day Track No User Fee |
| S022 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S021 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S020 | 2010-09-27 | 30-day Notice |
| S019 | 2010-07-26 | Normal 180 Day Track No User Fee |
| S018 | 2010-04-02 | Real-time Process |
| S017 | 2008-05-21 | Normal 180 Day Track |
| S016 | 2007-01-17 | 30-day Notice |
| S015 | 2005-08-12 | Special (immediate Track) |
| S014 | ||
| S013 | 2005-05-05 | Real-time Process |
| S012 | 2004-08-30 | 30-day Notice |
| S011 | 2004-07-29 | Real-time Process |
| S010 | 2004-04-01 | Real-time Process |
| S009 | 2003-01-31 | Normal 180 Day Track |
| S008 | 2002-03-18 | Special (immediate Track) |
| S007 | 2001-12-05 | Normal 180 Day Track |
| S006 | 2001-06-15 | Normal 180 Day Track |
| S005 | 1997-09-25 | Real-time Process |
| S004 | 1994-11-02 | Panel Track |
| S003 | 1994-08-29 | Special (immediate Track) |
| S002 | 1994-04-04 | Normal 180 Day Track |
| S001 | 1992-08-26 | Normal 180 Day Track |