FoundationOne®Liquid CDx

FDA Premarket Approval P200016 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

DeviceFoundationOne®Liquid CDx
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200016 Supplement NumberS001 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP  Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-08-22
Decision Date2022-09-21
PMAP200016
SupplementS001
Product CodePQP 
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressFoundation Medicine, Inc.
150 Second Street
cambridge, MA 02141 PMA NumberP200016 Supplement NumberS001 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP  Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For The Formatting And Updates To The Specimen Instructions Document, The Technical Labeling, And The Mock Patient Reports For FoundationOne® Liquid CDx

Supplemental Filings

Supplement NumberDateSupplement Type
P200016Original Filing
S001 2022-08-22 Special (immediate Track)

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