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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.
DeviceAbbott RealTime IDH1
Generic NameSomatic gene mutation detection system
ApplicantAbbott Molecular, Inc.
1300 East Touhy Avenue
Des Plaines, IL 60018
PMA NumberP170041
Supplement NumberS007
Date Received06/27/2023
Decision Date10/24/2023
Product Code OWD 
Advisory Committee
Clinical TrialsNCT02074839
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for expanding the indication for use of Abbott RealTime IDH1 as an aid in identifying myelodysplastic syndrome (MDS) patients with isocitrate dehydrogenase-1 (IDH1) mutation for treatment with TIBSOVO® (ivosidenib).