PMA P190028S019

Device: cobas HPV for use on the cobas 6800/8800 Systems
Applicant: Roche Molecular Systems, Inc.
PMA number: P190028
Supplement: S019
Product code: MAQ
Decision date: 2025-03-27
Classification: Microbiology
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval of the for the post-approval study (PAS) referenced above. The PAS protocols have been submitted to comply with the conditions of approval outlined in our approval order for P190028/S009.

Current openFDA PMA Record#

Device: cobas HPV for use on the cobas 6800/8800 Systems
Applicant: Roche Molecular Systems, Inc.
PMA number: P190028
Supplement: S019
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2025-03-27
Decision code: APPR
Date received: 2025-02-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval of the for the post-approval study (PAS) referenced above. The PAS protocols have been submitted to comply with the conditions of approval outlined in our approval order for P190028/S009.