GORE CARDIOFORM Septal Occluder

FDA premarket approval P050006/S060 · decided 2018-03-30

Approval details

PMA number

P050006

Supplement

S060

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

GORE CARDIOFORM Septal Occluder

Generic name

Transcatheter septal occluder

Applicant

W. L. Gore & Associates, Inc.

Date received

2017-07-31

Decision date

2018-03-30

Days to decision

242 days

Decision code

APPR

Product code

MLV

Advisory committee

Cardiovascular

Expedited review

No

Location

Phonix, AZ

Statement

Approval for the GORE CARDIOFORM Septal Occluder. The GORE CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum:1) ostium secundum atrial septal defects (ASDs); and2) 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 determine

510(k) clearances by this applicant