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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.
 
DeviceCOBAS EGFR MUTATION TEST
Generic NameSomatic gene mutation detection system
ApplicantRoche
4300 Hacienda Dr.
P.O. Box 9002
Peasanton, CA 94588
PMA NumberP120019
Supplement NumberS005
Date Received12/19/2014
Decision Date01/15/2015
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE HPLC SYSTEM QUALIFICATION RETENTION TIME WINDOW FOR THE PURIFICATION OF AN OLIGONUCLEOTIDE.
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