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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
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 NumberS004
Date Received09/24/2018
Decision Date07/01/2019
Product Code
PQP[ Registered Establishments with PQP ]
Advisory Committee Pathology
Clinical Trials NCT01844986
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 LYNPARZA (olaparib) in ovarian cancer patients with BRCA1/2 alterations.
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