Dimension® FPSA Flex® reagent cartridge

FDA Premarket Approval P020027 S039

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® FPSA Flex® reagent cartridge
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2021-11-18
Decision Date2021-12-20
PMAP020027
SupplementS039
Product CodeMTG 
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, P O Box 6101 m/s 514 newark, DE 19714-6101

Supplemental Filings

Supplement NumberDateSupplement Type
P020027Original Filing
S039 2021-11-18 30-day Notice
S038 2020-09-14 30-day Notice
S037
S036 2019-06-19 30-day Notice
S035 2019-05-13 30-day Notice
S034 2018-09-28 Real-time Process
S033 2018-06-18 30-day Notice
S032 2018-04-17 30-day Notice
S031
S030 2017-11-20 30-day Notice
S029 2017-10-16 30-day Notice
S028 2017-09-25 Normal 180 Day Track No User Fee
S027 2017-06-20 30-day Notice
S026 2017-04-26 30-day Notice
S025 2017-02-17 30-day Notice
S024 2016-08-03 30-day Notice
S023 2015-12-07 Normal 180 Day Track
S022 2015-06-04 135 Review Track For 30-day Notice
S021 2014-08-27 30-day Notice
S020 2013-05-03 30-day Notice
S019 2012-10-31 30-day Notice
S018 2012-03-08 30-day Notice
S017 2012-02-01 Real-time Process
S016 2011-11-22 30-day Notice
S015 2011-06-30 Normal 180 Day Track
S014 2010-10-18 Real-time Process
S013 2010-08-19 Normal 180 Day Track
S012 2010-07-06 Real-time Process
S011 2010-03-25 30-day Notice
S010 2009-05-26 Normal 180 Day Track
S009 2008-12-02 Normal 180 Day Track
S008 2008-03-03 Special (immediate Track)
S007 2008-02-26 30-day Notice
S006 2007-08-14 Real-time Process
S005 2006-12-06 30-day Notice
S004 2005-06-29 30-day Notice
S003 2005-04-01 Special (immediate Track)
S002 2005-01-31 30-day Notice
S001 2003-09-29 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00842768013751 P020027 000
00842768013881 P020027 001
00842768016677 P020027 009

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