PMA P120003S006

Device: iCast Covered Stent System
Applicant: Atrium Medical Corp.
PMA number: P120003
Supplement: S006
Product code: PRL
Decision date: 2025-07-07
Classification: Cardiovascular
Generic name: Iliac covered stent, arterial
Approval order statement: approval for a labeling update to reflect the use of the iCast Covered Stent System as a bridging stent between a branch vessel and an endovascular graft for treatment of patients with aneurysmal disease, limited to endovascular grafts that are approved for use with iCast

Current openFDA PMA Record#

Device: iCast Covered Stent System
Applicant: Atrium Medical Corp.
PMA number: P120003
Supplement: S006
Product code: PRL
Generic name: Iliac covered stent, arterial
Decision date: 2025-07-07
Decision code: APPR
Date received: 2024-08-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a labeling update to reflect the use of the iCast Covered Stent System as a bridging stent between a branch vessel and an endovascular graft for treatment of patients with aneurysmal disease, limited to endovascular grafts that are approved for use with iCast