Dimension® TPSA Flex® reagent cartridge

FDA Premarket Approval P000021 S044

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

Addition of an alternate supplier for the lens and mirror components used in photometer assembly on the dimension family of instruments.

DeviceDimension® TPSA Flex® reagent cartridge
Generic NameProstate-specific Antigen (psa) For Management Of Prostate Cancers
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2021-11-18
Decision Date2021-12-20
PMAP000021
SupplementS044
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 500 Gbc Drive po Box 6101 newark, DE 19714-6101

Supplemental Filings

Supplement NumberDateSupplement Type
P000021Original Filing
S044 2021-11-18 30-day Notice
S043 2020-09-14 30-day Notice
S042
S041 2019-06-19 30-day Notice
S040 2019-05-13 30-day Notice
S039 2018-09-28 Real-time Process
S038 2018-06-18 30-day Notice
S037 2018-04-17 30-day Notice
S036
S035 2017-11-20 30-day Notice
S034 2017-10-16 30-day Notice
S033 2017-09-25 Normal 180 Day Track No User Fee
S032 2017-06-20 30-day Notice
S031 2017-04-26 30-day Notice
S030 2017-02-17 30-day Notice
S029 2016-08-03 30-day Notice
S028 2015-12-07 Normal 180 Day Track
S027 2015-06-04 135 Review Track For 30-day Notice
S026 2014-08-27 30-day Notice
S025 2013-05-03 30-day Notice
S024 2012-10-31 30-day Notice
S023 2012-03-20 Real-time Process
S022 2012-03-08 30-day Notice
S021 2011-11-22 30-day Notice
S020 2011-06-30 Normal 180 Day Track
S019 2010-10-18 Real-time Process
S018 2010-08-19 Normal 180 Day Track
S017 2010-07-06 Real-time Process
S016 2010-03-25 30-day Notice
S015 2009-05-19 Normal 180 Day Track
S014 2009-04-06 Real-time Process
S013 2008-12-02 Normal 180 Day Track
S012 2008-03-03 Special (immediate Track)
S011 2008-02-26 30-day Notice
S010 2007-08-14 Real-time Process
S009 2006-12-06 30-day Notice
S008 2005-06-24 30-day Notice
S007
S006 2005-04-01 Special (immediate Track)
S005 2005-01-31 30-day Notice
S004 2004-11-15 Real-time Process
S003 2003-12-17 Real-time Process
S002 2002-03-26 Normal 180 Day Track
S001 2001-07-12 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00842768013874 P000021 001
00842768016660 P000021 013

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