Tack Endovascular System (6F)

FDA Premarket Approval P180034 S005

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

Labeling updates which incorporate the final 36-month results from the toba ii post approval study.

DeviceTack Endovascular System (6F)
Generic NameScaffold, Dissection Repair
ApplicantPhilips Image Guided Therapy Corporation
Date Received2021-06-10
Decision Date2021-09-07
Product CodeQCT 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address Philips Image Guided Therapy Corporation 5905 Nathan Lane North plymouth, MN 55442

Supplemental Filings

Supplement NumberDateSupplement Type
P180034Original Filing
S005 2021-06-10 Normal 180 Day Track No User Fee
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.