Atellica IM Complexed PSA (cPSA) Assay

FDA Premarket Approval P990055 S023

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

For moving manufacturing of atellica im analyzer’s component/subassembly named autoloader to an internal supplier

DeviceAtellica IM Complexed PSA (cPSA) Assay
Generic NameAntigen(complexed),prostate Specific,(cpsa)
Date Received2021-04-01
Decision Date2021-04-27
Product CodeNAF 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement NumberDateSupplement Type
P990055Original Filing
S023 2021-04-01 30-day Notice
S022 2020-07-31 30-day Notice
S021 2020-03-09 30-day Notice
S020 2020-02-21 30-day Notice
S018 2019-02-01 30-day Notice
S017 2018-07-27 Real-time Process
S016 2017-09-29 Normal 180 Day Track
S015 2015-05-07 Normal 180 Day Track
S014 2012-03-26 Normal 180 Day Track No User Fee
S013 2010-08-06 30-day Notice
S012 2009-04-10 Normal 180 Day Track No User Fee
S011 2009-02-06 30-day Notice
S010 2009-03-06 Real-time Process
S009 2006-05-17 Normal 180 Day Track No User Fee
S008 2005-07-22 Real-time Process
S007 2003-07-16 Real-time Process
S006 2003-04-21 Real-time Process
S005 2002-03-28 Normal 180 Day Track
S004 2002-03-06 Normal 180 Day Track
S003 2001-09-20 Normal 180 Day Track
S002 2001-09-20 Normal 180 Day Track
S001 2001-03-27 Normal 180 Day Track


Device IDPMASupp
00630414598710 P990055 001
00630414450896 P990055 001
00630414451114 P990055 001
00630414451558 P990055 001
00630414451732 P990055 001
00630414598475 P990055 001
00630414598680 P990055 001
00630414598697 P990055 001
00630414598703 P990055 001
00630414450872 P990055 001

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