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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
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 NumberS006
Date Received12/26/2018
Decision Date12/03/2019
Product Code PQP 
Docket Number 19M-5741
Notice Date 12/06/2019
Advisory Committee Pathology
Clinical TrialsNCT02437318
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval order for extending the label claim to include an indication for PIQRAY (alpelisib) in breast cancer patients with PIK3CA C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y alterations.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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