Premarket Approval (PMA)

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.

• Device: FoundationOne Liquid CDx
• Generic Name: Next generation sequencing oncology panel, somatic or germline variant detection system
• Applicant: Foundation Medicine, Inc.; 150 Second St.; Cambridge, MA 02141
• PMA Number: P200016
• Supplement Number: S002
• Date Received: 09/09/2022
• Decision Date: 03/08/2023
• APCB Date: 05/26/2023
• Product Code: PQP
• Advisory Committee: Molecular Genetics
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for Waiver of Condition of Approval (CoA) for Contrived Sample Functional Characterization (CSFC) study for F1 Liquid CDx.