VIDAS TOTAL PSA (TPSA)

FDA Premarket Approval P040008 S002

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

Add an alternate supplier of the critical component solid phase receptacle (spr-pm) for the vidas® total psa and free psa products.

DeviceVIDAS TOTAL PSA (TPSA)
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantBioMerieux, Inc.
Date Received2012-01-09
Decision Date2012-02-08
PMAP040008
SupplementS002
Product CodeMTF 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042

Supplemental Filings

Supplement NumberDateSupplement Type
P040008Original Filing
S013 2016-05-03 30-day Notice
S012 2015-07-06 30-day Notice
S011 2015-03-18 30-day Notice
S010
S009
S008 2014-02-03 30-day Notice
S007 2013-08-15 30-day Notice
S006 2013-02-12 30-day Notice
S005 2013-02-06 30-day Notice
S004 2012-12-18 30-day Notice
S003 2012-10-11 Real-time Process
S002 2012-01-09 30-day Notice
S001 2008-09-04 30-day Notice

NIH GUDID Devices

Device IDPMASupp
03573026156985 P040008 000

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