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. |
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Device | FoundationOne CDx (F1CDx) |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Foundation Medicine, Inc. 150 Second Street, 1st Floor Cambridge, MA 02141 |
PMA Number | P170019 |
Supplement Number | S019 |
Date Received | 04/27/2020 |
Decision Date | 07/24/2020 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of software infrastructure modifications for FoundationOne CDx (F1CDx), including modifications involving migrating the analysis pipeline and associated software to the Amazon Web Services (AWS) cloud. |
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