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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.
 
DeviceoncoRevealTM CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantPillar Biosciences
9 Strathmore Rd.
Natick, MA 01760
PMA NumberP200011
Supplement NumberS001
Date Received07/11/2022
Decision Date04/18/2024
Product Code PQP 
Advisory Committee Molecular Genetics
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
This supplement is being approved for the oncoReveal CDx to expand the intended use and indication for use of oncoReveal CDx to include tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients with solid malignant neoplasms.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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