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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.
150 Second Street, 1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS036
Date Received08/01/2022
Decision Date09/18/2023
Product Code PQP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a DNA/RNA CoExtraction (CoEx) method, and removal of reporting of copy number alterations (amplifications and deletions/losses) for the tumor profiling indication from the intended use/indications for use when using the DNA/RNA CoEx method.
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