FoundationOne CDx (F1CDx)

FDA Premarket Approval P170019 S019

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

Approval of software infrastructure modifications for foundationone cdx (f1cdx), including modifications involving migrating the analysis pipeline and associated software to the amazon web services (aws) cloud

DeviceFoundationOne CDx (F1CDx)
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine, Inc.
Date Received2020-04-27
Decision Date2020-07-24
PMAP170019
SupplementS019
Product CodePQP 
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Foundation Medicine, Inc. 150 Second Street, 1st Floor cambridge, MA 02141

Supplemental Filings

Supplement NumberDateSupplement Type
P170019Original Filing
S019 2020-04-27 Real-time Process
S018 2020-04-16 30-day Notice
S017
S016
S015 2019-12-16 Panel Track
S014
S013 2019-10-31 Panel Track
S012 2019-10-21 Special (immediate Track)
S011
S010
S009 2019-07-23 Special (immediate Track)
S008 2019-04-09 Normal 180 Day Track
S007
S006
S005 2018-10-12 Normal 180 Day Track
S004 2018-09-24 Normal 180 Day Track
S003 2018-08-30 Real-time Process
S002 2018-08-24 Real-time Process
S001

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