Aptima HBV Quant Assay

FDA Premarket Approval P170025 S017

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 NumberS017 Date Received12/14/2021 Decision Date02/25/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2021-12-14
Decision Date2022-02-25
PMAP170025
SupplementS017
Product CodeMKT 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressHologic, Inc
10210 Genetic Center Drive
san Diego, CA 92121 PMA NumberP170025 Supplement NumberS017 Date Received12/14/2021 Decision Date02/25/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval To Support The Addition Of The Optional Use Of An Automated Dishwasher (Miele Dishwasher) To Wash Panther Trax Shuttle Shields, Sample Racks, And Storage Racks Used With The Aptima HPV Assays.

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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