FoundationOne Liquid CDx (F1 Liquid CDx)

FDA Premarket Approval P190032 S001

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 to include a companion diagnostic indication for detection of met single nucleotide variants (snvs) and indels that lead to met exon 14 skipping in non-small cell lung cancer patients who may benefit from treatment with tabrecta (capmatinib)

DeviceFoundationOne Liquid CDx (F1 Liquid CDx)
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine Inc.
Date Received2020-08-28
Decision Date2021-07-15
PMAP190032
SupplementS001
Product CodePQP 
Advisory CommitteePathology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Foundation Medicine Inc. 150 Second Street cambridge, MA 02141

Supplemental Filings

Supplement NumberDateSupplement Type
P190032Original Filing
S001 2020-08-28 Panel Track

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