Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: COBAS 4800 BRAF V600 MUTATION TEST
• Classification Name: somatic gene mutation detection system
• Applicant: ROCHE MOLECULAR SYSTEMS, INC.
• PMA Number: P110020
• Supplement Number: S005
• Date Received: 08/17/2012
• Decision Date: 09/14/2012
• Product Code: OWD [ Registered Establishments with OWD ]
• Advisory Committee: Immunology
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Change to adjust the environmental testing performed at the rms branchburg facility.