ATLAS+ DR/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE

FDA premarket approval P910023/S069 · decided 2003-10-17

Approval details

PMA number

P910023

Supplement

S069

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ATLAS+ DR/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

2003-09-11

Decision date

2003-10-17

Days to decision

36 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR MODIFICATIONS TO THE EPIC+ ICDS TO INCLUDE HIGHER ENERGY OUTPUT, SOFTWARE MODIFICATIONS, AND A DIFFERENT HEADER TYPE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODELS V-242, V-243, V-193 AND V-193C, EPIC+ MODELS V-233, V-239 AND V196, AND MODEL 3307 V.4.5A SOFTWARE, AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICU

510(k) clearances by this applicant