AMPLATZER MUSCULAR VSD OCCLUDER

FDA premarket approval P040040 · decided 2007-09-07

Approval details

PMA number

P040040

Trade name

AMPLATZER MUSCULAR VSD OCCLUDER

Generic name

Transcatheter septal occluder

Applicant

ABBOTT MEDICAL

Date received

2004-09-30

Decision date

2007-09-07

Days to decision

1072 days

Decision code

APPR

Product code

MLV

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

APPROVAL FOR THE AMPLATZER MUSCULAR VSD OCCLUDER. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE (LARGE VOLUME LEFT TO RIGHT SHUNT, PULMONARY HYPERTENSION AND/OR CLINICAL SYMPTOMS OF CONGESTIVE HEART FAILURE) WHO ARE CONSIDERED TO BE AT HIGH RISK FOR STANDARD TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE BASED ON ANATOMICAL CONDITIONS AND/OR BASED ON OVERALL MEDICAL CONDITION. HIGH RISK ANATOMICAL FACTORS FOR TRAN

510(k) clearances by this applicant