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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)
Classification Namenext generation sequencing oncology panel, somatic or germline variant detection system
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
Applicant
Foundation Medicine, Inc.
150 second street, 1st floor
cambridge, MA 02141
PMA NumberP170019
Supplement NumberS008
Date Received04/09/2019
Decision Date07/01/2019
Product Code
PQP[ Registered Establishments with PQP ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval order for extending the label claim to include an indication for TAGRISSO (osimertinib) in non-small cell lung cancer patients with EGFR exon 19 deletions and EGFR exon 21 L858R alterations.
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