cobas CMV

FDA Premarket Approval P160041 S028

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

Change of a supplier's manufacturing site for a critical component

Devicecobas CMV
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantROCHE MOLECULAR SYSTEMS, INC.
Date Received2020-01-10
Decision Date2020-02-06
PMAP160041
SupplementS028
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
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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