Tack Endovascular System (6F)

FDA Premarket Approval P180034 S003

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

Pad printed component supplier change.

DeviceTack Endovascular System (6F)
Generic NameScaffold, Dissection Repair
ApplicantIntact Vascular, Inc.
Date Received2020-09-01
Decision Date2020-09-28
PMAP180034
SupplementS003
Product CodeQCT 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Intact Vascular, Inc. 1285 Drummers Lane, Suite 200 wayne, PA 19087

Supplemental Filings

Supplement NumberDateSupplement Type
P180034Original Filing
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 IDPMASupp
00863328000103 P180034 000
00863328000127 P180034 000
00863328000110 P180034 000
00850003494050 P180034 001
00850003494043 P180034 001
00850003494036 P180034 001

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.