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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 IDH2
Generic NameSomatic gene mutation detection system
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP170005
Supplement NumberS006
Date Received05/05/2026
Decision Date05/28/2026
Product Code OWD 
Advisory Committee Molecular Genetics
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementation of manufacturing changes
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