COBAS AmpliPrep/COBAS TaqMan CMV Test

Cytomegalovirus (cmv) Dna Quantitative Assay

FDA Premarket Approval P110037 S051

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 critical components

DeviceCOBAS AmpliPrep/COBAS TaqMan CMV Test
Classification NameCytomegalovirus (cmv) Dna Quantitative Assay
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantRoche Molecular Systems, Inc.
Date Received2019-10-08
Decision Date2019-11-05
PMAP110037
SupplementS051
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
P110037Original Filing
S051 2019-10-08 30-day Notice
S050 2019-09-20 30-day Notice
S049 2019-08-16 30-day Notice
S048 2019-07-15 Special (immediate Track)
S047 2019-04-24 30-day Notice
S046 2019-04-10 30-day Notice
S045 2019-03-20 30-day Notice
S044 2018-12-14 30-day Notice
S043 2018-11-13 30-day Notice
S042 2018-11-09 30-day Notice
S041 2018-08-21 30-day Notice
S040 2018-07-27 30-day Notice
S039 2018-06-29 30-day Notice
S038 2018-06-08 30-day Notice
S037 2018-06-04 30-day Notice
S036 2018-04-16 30-day Notice
S035 2018-04-16 30-day Notice
S034 2018-03-01 30-day Notice
S033 2017-11-14 30-day Notice
S032 2017-09-26 30-day Notice
S031 2017-07-14 30-day Notice
S030 2017-07-14 30-day Notice
S029 2016-09-22 30-day Notice
S028 2016-07-19 30-day Notice
S027 2016-07-08 30-day Notice
S026 2016-04-18 30-day Notice
S025 2016-04-07 30-day Notice
S024 2015-11-17 Real-time Process
S023 2015-10-22 Normal 180 Day Track
S022 2015-06-24 30-day Notice
S021 2015-04-09 30-day Notice
S020 2015-03-13 30-day Notice
S019 2015-02-25 Real-time Process
S018 2014-12-19 30-day Notice
S017 2014-12-19 30-day Notice
S016 2014-12-16 Real-time Process
S015 2014-03-31 30-day Notice
S014 2014-03-18 30-day Notice
S013 2014-02-18 30-day Notice
S012 2013-10-30 30-day Notice
S011 2013-09-09 30-day Notice
S010 2013-09-09 30-day Notice
S009 2013-08-14 30-day Notice
S008 2013-08-09 30-day Notice
S007 2013-07-26 30-day Notice
S006 2013-05-09 30-day Notice
S005 2013-02-19 Special (immediate Track)
S004 2012-11-16 Real-time Process
S003 2012-11-02 Real-time Process
S002 2012-08-15 30-day Notice
S001 2012-08-07 Real-time Process

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