Tack Endovascular System (4F, 1.5-4.5mm)

FDA Premarket Approval P190027 S002

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

An alternate supplier for the tip component of the delivery system

DeviceTack Endovascular System (4F, 1.5-4.5mm)
Generic NameScaffold, Dissection Repair
ApplicantPhilips Image Guided Therapy Corporation (formerly Intact)
Date Received2021-09-08
Decision Date2021-10-08
PMAP190027
SupplementS002
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 (formerly Intact) 5905 Nathan Lane North plymouth, MN 55442

Supplemental Filings

Supplement NumberDateSupplement Type
P190027Original Filing
S002 2021-09-08 30-day Notice
S001 2020-09-01 30-day Notice

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