PMA P180034S001

Device: Tack Endovascular System (6F)
Applicant: Philips Image Guided Therapy Corporation
PMA number: P180034
Supplement: S001
Product code: QCT
Decision date: 2020-01-28
Generic name: Scaffold, dissection repair
Approval order statement: 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).

Current openFDA PMA Record#

Device: Tack Endovascular System (6F)
Applicant: Philips Image Guided Therapy Corporation
PMA number: P180034
Supplement: S001
Product code: QCT
Generic name: Scaffold, dissection repair
Decision date: 2020-01-28
Decision code: APPR
Date received: 2019-08-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: 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).