EPIC AND ATLAS+ HF CRT-D SYSTEMS

FDA premarket approval P030054/S010 · decided 2005-11-18

Approval details

PMA number

P030054

Supplement

S010

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

EPIC AND ATLAS+ HF CRT-D SYSTEMS

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2005-06-06

Decision date

2005-11-18

Days to decision

165 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE MODIFICATION OF THE INDICATIONS FOR THE EPIC AND ATLAS+ HF CRT-D SYSTEMS, SPECIFICALLY THE MAINTENANCE OF SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. THE ST. JUDE MEDICAL THE EPIC AND ATLAS+ HF CRT-D SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING V

510(k) clearances by this applicant