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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 (F1CDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
400 Summer St.
Boston, MA 02210
PMA NumberP170019
Supplement NumberS009
Date Received07/23/2019
Decision Date08/21/2019
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changing the reporting of some microsatellite stable results to Microsatellite Status-Cannot be Determined and to add a disclaimer in your report where you report microsatellite status and in the limitations section of the report indicating Patients with ‘Microsatellite Status-Cannot be Determined’ should be retested with an orthogonal (alternative) method.
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