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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 4800 BRAF V600 MUTATION TEST
Generic NameSomatic gene mutation detection system
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP110020
Supplement NumberS002
Date Received09/29/2011
Decision Date10/26/2011
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
CHANGES TO THE FILLING AND LABELING EQUIPMENT AND LOCATION FOR CERTAIN VIALED INTERMEDIATE COMPONENTS. YOUR FIRM HAS PROPOSED RELOCATION TO BUILDING 502 ROOMS1F24 AND 1F26 FROM BUILDING 502 ROOMS 1F23 AND 1F31 FOR USE OF NEW EQUIPMENT KUGLER LINOLINE 120 FILING AND SCREW-CAPPING LINE WHICH INCLUDES THE ACCRAPLY 4000 AND 35T LABELINGMACHINES.
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