Tack Endovascular System (4F)

FDA Premarket Approval P190027 S001

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 (4F)
Generic NameScaffold, Dissection Repair
ApplicantIntact Vascular, Inc.
Date Received2020-09-01
Decision Date2020-09-28
PMAP190027
SupplementS001
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, #200 wayne, PA 19087

Supplemental Filings

Supplement NumberDateSupplement Type
P190027Original Filing
S001 2020-09-01 30-day Notice

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