Tack Endovascular System (6F)

FDA Premarket Approval P180034 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

Approval for the tack endovascular system® (6f, 4. 0-8. 0mm) for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 4. 0mm to 8. 0mm for the repair of post percutaneous transluminal balloon angioplasty dissection(s).

DeviceTack Endovascular System (6F)
Generic NameScaffold, Dissection Repair
ApplicantIntact Vascular, Inc.
Date Received2019-08-02
Decision Date2020-01-28
PMAP180034
SupplementS001
Product CodeQCT 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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
S001 2019-08-02 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00863328000103 P180034 000
00863328000127 P180034 000
00863328000110 P180034 000

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