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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.
Devicetherascreen EGFR RGQ PCR Kit
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
skelton house
lloyd street north
manchester M15 6
PMA NumberP120022
Supplement NumberS018
Date Received02/16/2018
Decision Date09/27/2018
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Clinical Trials NCT01774721
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for to extend the intended use of the therascreen® EGFR RGQ PCR Kit to include the selection of patients with NSCLC for whom dacomitinib is indicated.