Philips Image Guided Therapy Corp Formerly Intact 5905 Nathan Lane Northplymouth Mn 55442 Pma Numberp190027 Supplement Numbers005 Date Received08 29 2022 Decision Date11 09 2022 Product Code Qct Advisory Committee Cardiovascular Clinical Trialsnct02942966 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 Numbers005 Date Received08 29 2022 Decision Date11 09 2022 Product Code Qct Advisory Committee Cardiovascular Clinical Trialsnct02942966 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 NumberS005 Date Received08/29/2022 Decision Date11/09/2022 Product Code QCT  Advisory Committee Cardiovascular Clinical TrialsNCT02942966 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
Tack Endovascular System (4F, 1.5-4.5mm)2022-11-09

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