AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE

FDA premarket approval P000039/S010 · decided 2005-10-13

Approval details

PMA number

P000039

Supplement

S010

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE

Generic name

OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Applicant

ABBOTT MEDICAL

Date received

2005-07-21

Decision date

2005-10-13

Days to decision

84 days

Decision code

APPR

Product code

MAE

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

Approval for changes to the labeling to support compatibility of the devices with MR environments up to 3.0 Tesla. The device, as modified, will be marketed under the trade name AMPLATZER Septal Occluder (ASO) Device with the following indications for use: The AMPLATZER Septal Occluder (ASO) Device is indicated for the occlusion of atrial septal defects (ASD) in secundum position. The ASO device is also indicated in patients who have undergone a fenestrated Fontan procedure and who now require c

510(k) clearances by this applicant