Amplatzer Pfo Occluder

FDA premarket approval P120021 · Transcatheter septal occluder

PMA numberP120021

Approval

Applicant
Abbott Medical
Received
November 30, 2012
Decision date
October 28, 2016 (APPR)
Supplements
26, latest May 28, 2026
Product code
MLV – Transcatheter Septal Occluder

Official FDA PMA record

Approval order statement

Approval for the AMPLATZER PFO Occluder. The device is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.