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

• Device: Tack Endovascular System
• Generic Name: Scaffold, Dissection Repair
• Applicant: Philips Image Guided Therapy Corporation
• Date Received: 2021-02-23
• Decision Date: 2021-03-16
• PMA: P180034
• Supplement: S004
• Product Code: QCT
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Philips Image Guided Therapy Corporation 6655 Wedgwood Road North, Suite 105 maple Grove, MN 55311

Supplemental Filings

Supplement Number	Date	Supplement Type
P180034		Original Filing
S007	2022-02-23	Normal 180 Day Track
S006
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

NIH GUDID Devices

Device ID	PMA	Supp
00863328000103	P180034	000
00863328000127	P180034	000
00863328000110	P180034	000
00850003494050	P180034	001
00850003494043	P180034	001
00850003494036	P180034	001