Praxis Extended RAS Panel

FDA Premarket Approval P160038 S016

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

Changes to the manufacturing processes

DevicePraxis Extended RAS Panel
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantIllumina, Inc.
Date Received2020-04-06
Decision Date2020-04-28
Product CodePQP 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Illumina, Inc. 5200 Illumina Way san Diego, CA 92122

Supplemental Filings

Supplement NumberDateSupplement Type
P160038Original Filing
S016 2020-04-06 30-day Notice
S015 2020-01-16 30-day Notice
S014 2019-10-29 30-day Notice
S013 2019-07-31 30-day Notice
S012 2019-04-24 30-day Notice
S010 2019-03-06 30-day Notice
S009 2019-02-15 30-day Notice
S008 2019-02-15 30-day Notice
S007 2018-12-10 30-day Notice
S006 2018-08-24 30-day Notice
S005 2018-08-06 30-day Notice
S004 2018-06-01 30-day Notice
S003 2018-04-04 30-day Notice
S002 2018-03-05 Special (immediate Track)
S001 2018-03-01 30-day Notice


Device IDPMASupp
00816270020088 P160038 000
00816270020088 P160038 000
00816270020088 P160038 000

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