Aptima HPV 16 18/45 Genotype Assay

FDA Premarket Approval P120007 S026

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

To add an alternate cleaning method for the sample shields and target capture reagent (tcr) adapters used on the panther/panther fusion instruments

DeviceAptima HPV 16 18/45 Genotype Assay
Generic NameKit, Rna Detection, Human Papillomavirus
ApplicantGEN-PROBE INCORPORATED
Date Received2019-12-23
Decision Date2020-01-21
PMAP120007
SupplementS026
Product CodeOYB 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P120007Original Filing
S026 2019-12-23 Real-time Process
S025
S024 2019-08-21 30-day Notice
S023 2019-08-02 30-day Notice
S022
S021 2019-03-27 30-day Notice
S020 2019-03-18 Real-time Process
S019 2019-03-01 Real-time Process
S018 2018-12-31 Real-time Process
S017 2018-08-31 30-day Notice
S016 2018-08-16 30-day Notice
S015 2018-03-15 30-day Notice
S014 2018-02-08 30-day Notice
S013 2017-12-20 30-day Notice
S012 2017-10-10 30-day Notice
S011 2017-09-01 Normal 180 Day Track
S010 2017-03-17 Real-time Process
S009 2016-08-15 30-day Notice
S008 2016-03-01 30-day Notice
S007 2015-10-16 30-day Notice
S006 2015-08-28 135 Review Track For 30-day Notice
S005
S004 2015-03-04 30-day Notice
S003 2014-12-24 Normal 180 Day Track No User Fee
S002 2014-04-17 Real-time Process
S001 2013-05-15 Normal 180 Day Track

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