Tack Endovascular System (4F)

FDA Premarket Approval P190027 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceTack Endovascular System (4F)
Generic NameScaffold, Dissection Repair
ApplicantPhilips 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
Date Received2022-02-23
Decision Date2022-05-24
PMAP190027
SupplementS004
Product CodeQCT 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressPhilips Image Guided Therapy Corporation (formerly Intact)
5905 Nathan Lane North
plymouth, 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 Combination ProductNo Approval Order Statement  
a Change Of Quality Management System And Design Ownership From Intact Vascular, Inc. To Philips Image Guided Therapy Corporation

Supplemental Filings

Supplement NumberDateSupplement Type
P190027Original Filing
S004 2022-02-23 Normal 180 Day Track
S003
S002 2021-09-08 30-day Notice
S001 2020-09-01 30-day Notice

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