cobas CMV

FDA Premarket Approval P160041 S031

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.

Pre-market Approval Supplement Details

The sponsor has proposed changes to the products identified above as the outcome of periodic internal reviews of hazard information. Per the sponsor, hazard information is compared against the most current safety data sheet to confirm whether any updates are reflected in product labeling. The sponsor notes that updates to the product hazard information strengthen instructions to enhance the safe use of the device. Review of the redlined versions of labeling, included in the submission, confirms that there are no changes to product formulation or changes to how the user interacts with the product. The changes do not pose any safety or efficacy concerns and accordingly are acceptable.

Devicecobas CMV
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantROCHE MOLECULAR SYSTEMS, INC.
Date Received2020-09-17
Decision Date2020-10-07
PMAP160041
SupplementS031
Product CodePAB 
Advisory CommitteeMicrobiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE MOLECULAR SYSTEMS, INC. 4300 Hacienda Drive pleasanton, CA 94588-2722

Supplemental Filings

Supplement NumberDateSupplement Type
P160041Original Filing
S031 2020-09-17 Special (immediate Track)
S030 2020-07-27 30-day Notice
S029 2020-04-17 30-day Notice
S028 2020-01-10 30-day Notice
S027 2019-11-29 30-day Notice
S026 2019-09-20 30-day Notice
S025 2019-08-30 30-day Notice
S024 2019-08-06 30-day Notice
S023
S022 2019-05-09 30-day Notice
S021 2019-05-09 30-day Notice
S020 2019-04-24 30-day Notice
S019 2019-04-24 30-day Notice
S018 2019-04-10 30-day Notice
S017 2019-04-03 30-day Notice
S016 2018-12-14 30-day Notice
S015 2018-11-13 30-day Notice
S014 2018-11-09 30-day Notice
S013 2018-08-21 30-day Notice
S012 2018-07-27 30-day Notice
S011 2018-06-29 30-day Notice
S010 2018-06-08 30-day Notice
S009 2018-06-04 30-day Notice
S008 2018-04-16 30-day Notice
S007 2018-03-01 30-day Notice
S006 2018-02-22 30-day Notice
S005 2018-01-23 30-day Notice
S004 2017-11-22 30-day Notice
S003 2017-10-30 30-day Notice
S002 2017-09-26 30-day Notice
S001 2017-07-14 30-day Notice

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.