FoundationOne Liquid CDx (F1 Liquid CDx)

FDA Premarket Approval P200006 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 (F1 Liquid CDx)
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200006 Supplement NumberS003 Date Received09/30/2022 Decision Date10/28/2022 Product Code PQP  Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-09-30
Decision Date2022-10-28
PMAP200006
SupplementS003
Product CodePQP 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressFoundation Medicine, Inc.
150 Second Street
cambridge, MA 02141 PMA NumberP200006 Supplement NumberS003 Date Received09/30/2022 Decision Date10/28/2022 Product Code PQP  Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Termination Of The Post-approval Study (PAS) Submitted Under P200006/S001 To Comply With The Clinical Condition Of Approval Outlined In The Approval Order For P200006. The Request For Termination Is Due To The Removal Of The Companion Diagnostic Indication For FoundationOne® Liquid CDx To Identify Patients With Ovarian Cancer Harboring BRCA1 Or BRCA2 Alterations For Treatment With Rucaparib As Approved Through P190032/S007.

Supplemental Filings

Supplement NumberDateSupplement Type
P200006Original Filing
S003 2022-09-30 Normal 180 Day Track No User Fee
S002 2022-08-22 Special (immediate Track)
S001 2021-03-23 Normal 180 Day Track No User Fee

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