Cobas CMV Test

Cytomegalovirus (cmv) Dna Quantitative Assay

FDA Premarket Approval P160041 S007

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

Modification of manufacturing fill line processes.

DeviceCobas CMV Test
Classification NameCytomegalovirus (cmv) Dna Quantitative Assay
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantROCHE MOLECULAR SYSTEMS, INC.
Date Received2018-03-01
Decision Date2018-03-26
PMAP160041
SupplementS007
Product CodePAB
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
S035 2022-05-31 Normal 180 Day Track
S034 2021-12-20 30-day Notice
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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