Hologic

FDA Filings

This page includes the latest FDA filings for Hologic. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K161575 HOLOGIC	Affirm Lateral Arm Upright Biopsy Accessory	2016-08-10

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• HOLOGIC, INC.
• HOLOGIC / GEN-PROBE INCORPORATED
• HOLOGIC, INC.250 Campus Drivemarlborough, MA 01752 PMA NumberP010013 Supplement NumberS089 Date Received11/02/2022 Decision Date12/01/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• HOLOGIC, INC.250 Campus Drivemarlborough, MA 01752 PMA NumberP010013 Supplement NumberS088 Date Received10/31/2022 Decision Date11/02/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• HOLOGIC, INC.250 Campus Drivemarlborough, MA 01752 PMA NumberP010013 Supplement NumberS087 Date Received08/03/2022 Decision Date08/04/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Hologic, 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
• Hologic, Inc.10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP210029 Supplement NumberS001 Date Received06/16/2022 Decision Date07/20/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Hologic, Inc.10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP210029 Date Received07/26/2021 Decision Date05/09/2022 Product Code PAB  Advisory Committee Microbiology Expedited Review Granted? No
• HOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS023 Date Received04/29/2022 Decision Date05/09/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• HOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS022 Date Received03/31/2022 Decision Date04/13/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• HOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS021 Date Received02/14/2022 Decision Date02/28/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Hologic, 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
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