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

FDA Filings

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

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
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
NovaSure Impedance Controlled Endometrial Ablation System2022-12-01

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