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 and cobas® EGFR Mutation Test, v2
• Generic Name: Somatic gene mutation detection system
• Applicant: ROCHE; 4300 HACIENDA DRIVE; PO BOX 9002; PLEASANTON, CA 94588
• PMA Number: P120019
• Supplement Number: S012
• Date Received: 09/22/2016
• Decision Date: 10/19/2016
• 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

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