Praxis Extended RAS Panel

FDA Premarket Approval P160038 S023

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

DevicePraxis Extended RAS Panel
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantIllumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS023 Date Received08/18/2022 Decision Date08/30/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-18
Decision Date2022-08-30
PMAP160038
SupplementS023
Product CodePQP 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressIllumina, Inc.
5200 Illumina Way
san Diego, CA 92122 PMA NumberP160038 Supplement NumberS023 Date Received08/18/2022 Decision Date08/30/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Change The Supplier Material For Manufacturing

Supplemental Filings

Supplement NumberDateSupplement Type
P160038Original Filing
S023 2022-08-18 30-day Notice
S022 2022-06-13 30-day Notice
S021 2022-02-28 30-day Notice
S020 2021-04-12 30-day Notice
S019
S018 2020-11-09 30-day Notice
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

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