Tack Endovascular System

FDA Premarket Approval P180034 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

Approval for an alternate supplier for the tip component of the delivery system

DeviceTack Endovascular System
Generic NameScaffold, Dissection Repair
ApplicantPhilips Image Guided Therapy Corporation
Date Received2021-02-23
Decision Date2021-03-16
Product CodeQCT 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Philips Image Guided Therapy Corporation 6655 Wedgwood Road North, Suite 105 maple Grove, MN 55311

Supplemental Filings

Supplement NumberDateSupplement Type
P180034Original Filing
S004 2021-02-23 30-day Notice
S003 2020-09-01 30-day Notice
S002 2020-03-17 30-day Notice
S001 2019-08-02 Normal 180 Day Track


Device IDPMASupp
00863328000103 P180034 000
00863328000127 P180034 000
00863328000110 P180034 000
00850003494050 P180034 001
00850003494043 P180034 001
00850003494036 P180034 001

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.