Premarket Approval (PMA)

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.

• Device: Cobas EGFR MUTATION TEST v2
• Generic Name: Somatic gene mutation detection system
• Applicant: Roche Molecular Systems, Inc.; 4300 Hacienda Dr.; Pleasanton, CA 94588
• PMA Number: P150047
• Supplement Number: S002
• Date Received: 09/22/2016
• Decision Date: 10/19/2016
• APCB Date: 05/05/2017
• Product Code: OWD
• Advisory Committee: Pathology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Implementation of AQL sampling in place of 100% visual inspection for filling line.