FDA Premarket Approval P120014 S012

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

For the transfer of manufacturing site location for a critical component

Generic NameSomatic Gene Mutation Detection System
ApplicantBioMerieux, Inc.
Date Received2021-11-23
Decision Date2021-12-20
Product CodeOWD 
Advisory CommitteePathology
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
P120014Original Filing
S012 2021-11-23 30-day Notice
S011 2021-02-12 30-day Notice
S010 2020-01-31 30-day Notice
S009 2019-08-07 30-day Notice
S008 2017-07-03 Normal 180 Day Track
S007 2016-10-27 30-day Notice
S006 2016-01-11 Normal 180 Day Track
S005 2015-05-08 30-day Notice
S004 2015-03-03 Special (immediate Track)
S003 2015-02-24 Normal 180 Day Track
S002 2014-10-15 135 Review Track For 30-day Notice
S001 2014-10-10 135 Review Track For 30-day Notice

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