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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
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP200006
Supplement NumberS002
Date Received08/22/2022
Decision Date09/21/2022
APCB Date 05/26/2023
Product Code PQP 
Advisory Committee Pathology
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.
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