DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Premarket Approval P000021 S027

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

Approval for the modified process of manufacturing thepolypropylene resin used in the production of dimension hm reaction vessels and the vista loci reaction vessels.

DeviceDIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
Classification NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2015-06-04
Decision Date2015-12-15
PMAP000021
SupplementS027
Product CodeMTF
Advisory CommitteeImmunology
Supplement Type135 Review Track For 30-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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