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: ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
• Generic Name: Next generation sequencing oncology panel, somatic or germline variant detection system
• Applicant: Pillar Biosciences; 9 Strathmore Rd.; Natick, MA 01760
• PMA Number: P200011
• Supplement Number: S002
• Date Received: 07/23/2024
• Decision Date: 09/27/2024
• Product Code: PQP
• Advisory Committee: Molecular Genetics
• Supplement Type: Real-Time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPR