Philips Image Guided Therapy Corp Formerly Intact 5905 Nathan Lane Northplymouth Mn 55442 Pma Numberp190027 Supplement Numbers004 Date Received02 23 2022 Decision Date05 24 2022 Product Code Qct Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Philips Image Guided Therapy Corp Formerly Intact 5905 Nathan Lane Northplymouth Mn 55442 Pma Numberp190027 Supplement Numbers004 Date Received02 23 2022 Decision Date05 24 2022 Product Code Qct Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material 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
Philips Image Guided Therapy Corporation (formerly Intact)5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP190027 Supplement NumberS004 Date Received02/23/2022 Decision Date05/24/2022 Product Code QCT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Tack Endovascular System (4F)2022-05-24

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