Aptima HBV Quant Assay

FDA Premarket Approval P170025 S018

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

DeviceAptima HBV Quant Assay
Generic NameHepatitis Viral B Dna Detection
ApplicantHologic, Inc10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP170025 Supplement NumberS018 Date Received06/16/2022 Decision Date07/20/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-16
Decision Date2022-07-20
PMAP170025
SupplementS018
Product CodeMKT 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressHologic, Inc
10210 Genetic Center Drive
san Diego, CA 92121 PMA NumberP170025 Supplement NumberS018 Date Received06/16/2022 Decision Date07/20/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Add Additional Monitoring And Final Release Criteria

Supplemental Filings

Supplement NumberDateSupplement Type
P170025Original Filing
S018 2022-06-16 30-day Notice
S017 2021-12-14 Real-time Process
S016 2020-07-09 30-day Notice
S015 2020-02-12 30-day Notice
S014 2019-12-23 Real-time Process
S013 2019-06-21 Normal 180 Day Track
S012 2019-04-19 30-day Notice
S011 2019-03-27 30-day Notice
S010 2019-03-18 Real-time Process
S009 2019-02-21 30-day Notice
S008 2019-01-31 30-day Notice
S007 2018-12-31 Real-time Process
S006 2018-11-29 30-day Notice
S005 2018-10-03 30-day Notice
S004 2018-05-11 135 Review Track For 30-day Notice
S003 2018-04-20 30-day Notice
S002 2018-03-12 30-day Notice
S001 2018-02-21 Normal 180 Day Track

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