cobas HPV Mg/Mn

FDA Premarket Approval P100020 S052

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

For a reagent manufacturing scale-up

Devicecobas HPV Mg/Mn
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantRoche Molecular Systems, Inc.
Date Received2020-06-01
Decision Date2020-06-24
PMAP100020
SupplementS052
Product CodeMAQ 
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
P100020Original Filing
S052 2020-06-01 30-day Notice
S051 2020-04-17 30-day Notice
S050 2019-09-20 30-day Notice
S049
S048 2019-08-08 30-day Notice
S047 2019-04-24 30-day Notice
S046 2019-04-10 30-day Notice
S045 2019-04-08 30-day Notice
S044 2019-04-03 30-day Notice
S043 2019-02-04 30-day Notice
S042 2018-12-14 30-day Notice
S041 2018-11-13 30-day Notice
S040 2018-11-09 30-day Notice
S039 2018-10-25 30-day Notice
S038 2018-08-21 30-day Notice
S037 2018-07-27 30-day Notice
S036 2018-06-29 30-day Notice
S035 2018-06-08 30-day Notice
S034 2018-06-04 30-day Notice
S033 2018-05-23 30-day Notice
S032 2018-05-09 Real-time Process
S031 2018-05-04 30-day Notice
S030 2018-04-16 30-day Notice
S029 2018-03-01 30-day Notice
S028 2017-12-07 30-day Notice
S027 2017-10-30 30-day Notice
S026 2017-09-26 30-day Notice
S025 2017-07-28 Normal 180 Day Track
S024 2017-07-17 30-day Notice
S023 2017-07-14 30-day Notice
S022 2017-07-14 30-day Notice
S021 2016-09-22 30-day Notice
S020 2016-07-08 30-day Notice
S019 2016-04-18 30-day Notice
S018 2016-04-07 30-day Notice
S017 2015-12-23 Panel Track
S016
S015 2015-06-24 30-day Notice
S014 2015-03-13 30-day Notice
S013 2015-02-25 Real-time Process
S012 2013-11-05 Real-time Process
S011 2013-08-14 30-day Notice
S010 2013-08-09 30-day Notice
S009 2013-07-26 30-day Notice
S008 2013-07-01 Panel Track
S007 2012-10-09 30-day Notice
S006 2012-08-15 30-day Notice
S005 2012-07-02 Real-time Process
S004 2012-04-02 Normal 180 Day Track
S003 2012-03-29 Normal 180 Day Track No User Fee
S002 2011-12-12 135 Review Track For 30-day Notice
S001 2011-05-31 Normal 180 Day Track No User Fee

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