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# Panel Backs St. Jude PFO Occluder System
- URL: https://www.fdaweb.com/panel-backs-st-jude-pfo-occluder-system/
- Published: 2016-05-27T12:00:00.000Z
- Updated: 2026-09-14T21:05:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135783

FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted 15 to 1 to recommend approval for a St. Jude Medical PMA for its Amplatzer Patent Foramen Ovale (PFO) Occluder System. The device is indicated for percutaneous, transcatheter closure of a PFO to prevent recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. The panel recommended that the labeling include language describing the clinical evaluation of a cryptogenic stroke in patients who might be candidates for the PFO Occluder. It also said the labeling needed a statement regarding the need for adjunctive anti-thrombotic therapy in patients treated with the device. Additionally, the panel recommended that patient selection be carefully considered and defined within the labeling.