AXSYM TOTAL PSA & ARCHITECT TOTAL PSA

FDA Premarket Approval P910007

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

• 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: 1991-03-01
• Decision Date: 1991-09-25
• Notice Date: 1991-11-12
• PMA: P910007
• Supplement: S
• Product Code: MTF
• Docket Number: 91M-0411
• Advisory Committee: Immunology
• Expedited Review: No
• Combination Product: No
• Applicant Address: Abbott Laboratories 100 Abbott Park Rd. abbott Park, IL 60064-3500

Supplemental Filings

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