IMMULITE/IMMULITE 1000/IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA

FDA Premarket Approval P930027 S023

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

Removal of redundant annual stability testing

DeviceIMMULITE/IMMULITE 1000/IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
Date Received2020-07-23
Decision Date2020-08-18
PMAP930027
SupplementS023
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
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
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00630414982212 P930027 003
00630414982205 P930027 003
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00630414982267 P930027 003
00630414982205 P930027 003
00630414982212 P930027 003
00630414982229 P930027 003
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00630414982205 P930027 003
00630414982212 P930027 003
00630414982229 P930027 003
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00630414982205 P930027 003
00630414982212 P930027 003
00630414982267 P930027 003
00630414982205 P930027 003
00630414982212 P930027 003
00630414982229 P930027 003
00630414982267 P930027 003
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00630414982205 P930027 003
00630414982212 P930027 003
00630414982229 P930027 003
00630414982267 P930027 003
00630414982205 P930027 003
00630414982267 P930027 003
00630414982267 P930027 003
00630414982229 P930027 003
00630414982212 P930027 003
00630414982205 P930027 003
00630414982267 P930027 003
00630414982212 P930027 003
00630414982229 P930027 003
00630414982229 P930027 003
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