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 AMPLIPREP/COBAS TAQMAN CMV TEST
• Generic Name: Cytomegalovirus (cmv) dna quantitative assay
• Regulation Number: 866.3180
• Applicant: Roche Molecular Systems, Inc.; 4300 Hacienda Dr.; Pleasanton, CA 94588
• PMA Number: P110037
• Supplement Number: S009
• Date Received: 08/14/2013
• Decision Date: 09/12/2013
• Reclassified Date: 10/23/2024
• Product Code: PAB
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.