FoundationOne CDx

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

FDA Premarket Approval P170019 S012

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

Adding fixed text language to the first page of the patient report indicating “for microsatellite instability (msi) results, confirmatory testing using a validated orthogonal method should be performed”

DeviceFoundationOne CDx
Classification NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine, Inc.
Date Received2019-10-21
Decision Date2019-11-06
PMAP170019
SupplementS012
Product CodePQP
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
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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