Hologic L T D

FDA Filings

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

FDA Filings

Device Company	Device	Date
GUDID 15420045512108 HOLOGIC LTD.	Aptima® PRD-04940	2024-07-03

Similar & Related FDA Registered Companies

• 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.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.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 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
• Hologic Ltd Tepnel Pharma Services

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018100472438	Rotterdam,Netherlands -> Boston, Massachusetts	MEDICAL EQUIPMENT	9 PKG