ST JUDE MEDICAL EPIC HF SYSTEM

FDA premarket approval P030054 · decided 2004-06-30

Approval details

PMA number

P030054

Trade name

ST JUDE MEDICAL EPIC HF SYSTEM

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

ABBOTT MEDICAL

Date received

2003-12-19

Decision date

2004-06-30

Days to decision

194 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE ST. JUDE MEDICAL EPIC HF SYSTEM AND THE ST. JUDE MEDICAL ATLAS + HF SYSTEM. THESE SYSTEMS ARE INDICATED FOR THE FOLLOWING: THE ST. JUDE MEDICAL EPIC HF AND ATLAS + HF SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. THE EPIC HF AND ATLAS + HF SYSTEMS ARE ALSO INTENDED TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLAS

510(k) clearances by this applicant