IMMULITE / IMMULITE 1000 FREE PSA

FDA Premarket Approval P060005 S013

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 FREE PSA
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
Date Received2021-04-14
Decision Date2021-04-28
PMAP060005
SupplementS013
Product CodeMTG 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED glyn Rhonwy. Llanberis caernarfon gwynedd, Ll55 4EL

Supplemental Filings

Supplement NumberDateSupplement Type
P060005Original Filing
S013 2021-04-14 30-day Notice
S012 2020-08-12 30-day Notice
S011 2020-07-23 30-day Notice
S010 2019-11-25 30-day Notice
S009 2018-09-28 Real-time Process
S008 2012-05-30 135 Review Track For 30-day Notice
S007 2011-12-19 135 Review Track For 30-day Notice
S006 2011-08-16 30-day Notice
S005 2011-08-08 30-day Notice
S004 2011-02-18 Real-time Process
S003 2009-11-02 Normal 180 Day Track No User Fee
S002
S001 2008-11-10 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00630414977478 P060005 001
00630414971575 P060005 001

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