EPIC + HF, ATLAS + HF, EPIC II + HF, ATLAS II + HF CARDIAC RESYNCHRONIZATION DEFIBRILLATORS

FDA premarket approval P030054/S034 · decided 2007-02-02

Approval details

PMA number

P030054

Supplement

S034

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

EPIC + HF, ATLAS + HF, EPIC II + HF, ATLAS II + HF CARDIAC RESYNCHRONIZATION DEFIBRILLATORS

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2006-07-19

Decision date

2007-02-02

Days to decision

198 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE ADDITION OF THE AF SUPPRESSION PACING FEATURE. THE SYSTEMS LISTED ABOVE ARE INDICATED AS FOLLOWS:THE SYSTEM IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION. IN PATIENTS INDICATED FOR AN ICD, THE SYSTEM IS

510(k) clearances by this applicant