PMA P980049S020

Device: OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S020
Product code: MRM
Decision date: 2006-04-28
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: APPROVAL FOR AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT COMBINES FEATURES OF THE ALTO 2 DR 624, ALTO 2 VR 625 ICDS, AND SYMPHONY 2550 PACEMAKER, INCLUDING REDUCED SIZE, MODIFIED SHOCK CIRCUITRY AND OTHER CHANGES. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD WITH HSO 2.76 SOFTWARE AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR TACHYARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO VENTRICULAR TACHYARRHYTHMIA, 2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).NOTE: THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE VT PATIENTS IS NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.

Current openFDA PMA Record#

Device: OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S020
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2006-04-28
Decision code: APPR
Date received: 2005-04-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT COMBINES FEATURES OF THE ALTO 2 DR 624, ALTO 2 VR 625 ICDS, AND SYMPHONY 2550 PACEMAKER, INCLUDING REDUCED SIZE, MODIFIED SHOCK CIRCUITRY AND OTHER CHANGES. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD WITH HSO 2.76 SOFTWARE AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR TACHYARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO VENTRICULAR TACHYARRHYTHMIA, 2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).NOTE: THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE VT PATIENTS IS NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.