cobas CMV

FDA Premarket Approval P160041 S033

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

An update to the hazard information on the product labeling for kits on the cobas 6800/8800 systems.

Devicecobas CMV
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantROCHE MOLECULAR SYSTEMS, INC.
Date Received2021-05-18
Decision Date2021-06-02
PMAP160041
SupplementS033
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
S033 2021-05-18 Special (immediate Track)
S032 2020-11-13 30-day Notice
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

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