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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
Applicant
Abbott Molecular Inc.
1300 e. touhy avenue
des plaines, IL 60018
PMA NumberP170005
Supplement NumberS003
Date Received02/05/2021
Decision Date03/03/2021
Product Code OWD 
Advisory Committee
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of alternative testing location for a device component.
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