ABBOTT IMX PSA

FDA Premarket Approval P910007 S004

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.

Pre-market Approval Supplement Details

Approval for the addition of a new intended use and is indicated for the quantitative measurement of prostate specific antigen (psa) in: 1) human serum as an adjunctive test used as an aid in the management of prostate cancer patients; 2) human serum as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men aged 50 years or older. Prostatic biopsy is required for diagnosis of cancer.

DeviceABBOTT IMX PSA
Generic NameProstate-specific Antigen (psa) For Management Of Prostate Cancers
ApplicantAbbott Laboratories
Date Received1994-11-02
Decision Date1997-08-07
PMAP910007
SupplementS004
Product CodeLTJ 
Docket Number97M-0501
Advisory CommitteeImmunology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Laboratories 100 Abbott Park Rd. abbott Park, IL 60064-3500

Supplemental Filings

Supplement NumberDateSupplement Type
P910007Original 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

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