FoundationOne Liquid CDx

FDA Premarket Approval P190032 S003

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 NumberP190032 Supplement NumberS003 Date Received10/28/2021 Decision Date05/25/2022 Product Code PQP  Advisory Committee Pathology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2021-10-28
Decision Date2022-05-25
PMAP190032
SupplementS003
Product CodePQP 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressFoundation Medicine Inc.
150 Second Street
cambridge, MA 02141 PMA NumberP190032 Supplement NumberS003 Date Received10/28/2021 Decision Date05/25/2022 Product Code PQP  Advisory Committee Pathology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Updating Of Dual Index Barcode (DIB) Primer From DIBv1 To DIBv2 For F1L CDx Device.

Supplemental Filings

Supplement NumberDateSupplement Type
P190032Original Filing
S003 2021-10-28 Normal 180 Day Track
S002
S001 2020-08-28 Panel Track

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