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 TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM
• Generic Name: Hepatitis Viral B DNA Detection
• Applicant: Roche Molecular Systems, Inc.; 4300 Hacienda Drive; Pleasanton, CA 94588-2722
• PMA Number: P050028
• Supplement Number: S022
• Date Received: 09/12/2011
• Decision Date: 10/11/2011
• Product Code: MKT
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CHANGES TO THE ROOM LOCATION AND EQUIPMENT FOR FILLING AND LABELING OF CERTAIN VIALED INTERMEDIATE COMPONENTS.