EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

FDA premarket approval P910023/S065 · decided 2003-04-23

Approval details

PMA number

P910023

Supplement

S065

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2003-02-07

Decision date

2003-04-23

Days to decision

75 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE EPIC PLUS DR/VR DEVICE WITH MODEL 3307 VERSION 4.3A PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-196 AND V-236) AND IS INDICATED 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

510(k) clearances by this applicant