AMPLATZER PFO OCCLUDER

FDA premarket approval P120021 · decided 2016-10-28

Approval details

PMA number

P120021

Trade name

AMPLATZER PFO OCCLUDER

Generic name

Transcatheter septal occluder

Applicant

ABBOTT MEDICAL

Date received

2012-11-30

Decision date

2016-10-28

Days to decision

1428 days

Decision code

APPR

Product code

MLV

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

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.

510(k) clearances by this applicant