ARCHITECT Free PSA / Alinity i Free PSA

FDA Premarket Approval P980007 S048

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

DeviceARCHITECT Free PSA / Alinity i Free PSA
ApplicantAbbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS048 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2023-01-06
Decision Date2023-01-27
PMAP980007
SupplementS048
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Laboratories
100 Abbott Park Rd.
ap5n-2 Dept 09vb
abbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS048 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Switch To A New Supplier Of A Noncritical Manufacturing Ingredient

Supplemental Filings

Supplement NumberDateSupplement Type
P980007Original 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.