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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceFoundationOne Liquid CDx (F1 Liquid CDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP200006
Supplement NumberS003
Date Received09/30/2022
Decision Date10/28/2022
APCB Date 05/26/2023
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  
Approval for the termination of the post-approval study (PAS) protocol.
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