Praxis Extended RAS Panel

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Premarket Approval P160038 S014

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

Replacement of an assembly sub-component.

DevicePraxis Extended RAS Panel
Classification NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantIllumina, Inc.
Date Received2019-10-29
Decision Date2019-11-04
PMAP160038
SupplementS014
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
S014 2019-10-29 30-day Notice
S013 2019-07-31 30-day Notice
S012 2019-04-24 30-day Notice
S011
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

NIH GUDID Devices

Device IDPMASupp
00816270020088 P160038 000
00816270020088 P160038 000
00816270020088 P160038 000

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