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.
To replace a sterile with a non-sterile bulk container for a kit component
| Device | ARCHITECT Total PSA (LN 6C06) |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | Abbott Laboratories |
| Date Received | 2021-11-09 |
| Decision Date | 2021-12-06 |
| PMA | P910007 |
| Supplement | S056 |
| 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 |