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 the addition of flomax to the analytical specificity section of the package insert and minor labeling changes to the abbott axsym free psa assay for the purpose of clarification, updates and conformation to requirements of the european community directives. The device, as modified, will be marketed under the same trade name axsym free psa assay and is indicated as follows: the axsym free psa assay is a microparticle enzyme immunoassay (meia) for the quantitative measurement of free prostate specific antigen (psa) in human serum. The axsym free psa assay is intended to be used in psa values between 4 and 10 ng/ml and non-suspicious dre to determine the % free psa value. The axsym % free psa value can be used as an aid in discriminating between prostate cancer and benign disease.
| Device | ABBOTT AXSYM FREE PSA ASSAY |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | Abbott Laboratories |
| Date Received | 2004-08-05 |
| Decision Date | 2004-09-10 |
| PMA | P980007 |
| Supplement | S005 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |