Dimension Vista FPSA Flex reagent cartridge

FDA Premarket Approval P020027 S038

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

Qualification of a new supplier for the luminescent oxygen channeling immunoassay reaction vessel used on the dimension vista instrument

DeviceDimension Vista FPSA Flex reagent cartridge
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2020-09-14
Decision Date2020-10-13
PMAP020027
SupplementS038
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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