VIDAS TOTAL PSA

FDA Premarket Approval P040008 S004

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

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• Device: VIDAS TOTAL PSA
• Generic Name: Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
• Applicant: BioMerieux, Inc.
• Date Received: 2012-12-18
• Decision Date: 2013-01-15
• PMA: P040008
• Supplement: S004
• Product Code: MTF
• Advisory Committee: Immunology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042

Supplemental Filings

Supplement Number	Date	Supplement Type
P040008		Original 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 ID	PMA	Supp
03573026156985	P040008	000