cobas® HPV

FDA Premarket Approval P100020 S054

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

Devicecobas® HPV
ApplicantRoche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP100020 Supplement NumberS054 Date Received10/21/2022 Decision Date11/14/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-21
Decision Date2022-11-14
PMAP100020
SupplementS054
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressRoche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton, CA 94588-2722 PMA NumberP100020 Supplement NumberS054 Date Received10/21/2022 Decision Date11/14/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
removal Of An In-process Testing (IPT) From The Manufacturing Process

Supplemental Filings

Supplement NumberDateSupplement Type
P100020Original Filing
S054 2022-10-21 30-day Notice
S053 2020-07-27 30-day Notice
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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