Praxis Extended RAS Panel

FDA Premarket Approval P160038 S017

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 implementation of two new quantitative quality control (qc) testing assays

DevicePraxis Extended RAS Panel
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantIllumina, Inc.
Date Received2020-08-04
Decision Date2020-09-02
PMAP160038
SupplementS017
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
S017 2020-08-04 30-day Notice
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
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.