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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 CDx, FoundationOne Liquid CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second Street, 1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS022
Date Received11/27/2020
Decision Date07/21/2021
Product Code PQP 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the variant classification procedure to add additional variants to existing BRCA1, BRCA2 and ATM companion diagnostic claims for PARP inhibitors (e.g., rucaparib and olaparib) on FoundationOne CDx and FoundationOne Liquid CDx
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