IMMULITE/IMMULITE 1000 THIRD GENERATION PSA

FDA Premarket Approval P930027 S025

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

Modify resin used in manufacture of test unit cap/body

DeviceIMMULITE/IMMULITE 1000 THIRD GENERATION PSA
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
Date Received2021-04-14
Decision Date2021-04-28
PMAP930027
SupplementS025
Product CodeMTF 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS INC. glyn Rhonwy, Llanberis gwynedd Ll55 4el LL554

Supplemental Filings

Supplement NumberDateSupplement Type
P930027Original Filing
S025 2021-04-14 30-day Notice
S024 2020-08-12 30-day Notice
S023 2020-07-23 30-day Notice
S022 2019-11-25 30-day Notice
S021 2019-06-19 Special (immediate Track)
S020 2018-09-28 Real-time Process
S019 2018-03-19 Special (immediate Track)
S018 2017-09-15 Special (immediate Track)
S017 2016-08-17 135 Review Track For 30-day Notice
S016 2014-07-23 135 Review Track For 30-day Notice
S015 2012-05-30 135 Review Track For 30-day Notice
S014 2011-12-19 135 Review Track For 30-day Notice
S013 2011-08-16 30-day Notice
S012 2011-08-08 30-day Notice
S011 2011-02-18 Real-time Process
S010 2009-11-02 Normal 180 Day Track No User Fee
S009
S008 2008-12-16 Normal 180 Day Track
S007 2008-11-10 Normal 180 Day Track No User Fee
S006 2003-11-28 Real-time Process
S005 2003-01-21 Real-time Process
S004 2001-01-02 Panel Track
S003 1998-02-20 Normal 180 Day Track
S002
S001 1995-10-18 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00630414954196 P930027 001
00630414982267 P930027 003
00630414982229 P930027 003
00630414982212 P930027 003
00630414982205 P930027 003
00630414982281 P930027 004

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