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 HPV TEST
• Generic Name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
• Applicant: Roche Molecular Systems, Inc.; 4300 Hacienda Dr.; Pleasanton, CA 94588
• PMA Number: P100020
• Supplement Number: S019
• Date Received: 04/18/2016
• Decision Date: 05/13/2016
• Product Code: MAQ
• Advisory Committee: Microbiology
• 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  
Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.