Defibrillator, Implantable, Dual-Chamber
Basic Information
- Device Name
- Defibrillator, Implantable, Dual-Chamber
- Trade Name
- OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD
- PMA Number
- P980049
- Supplement Number
- S020
- Device Class
- FDA Class 3
- Product Code
- MRM
- Generic Name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 28, 2006
- Date Received
- April 29, 2005
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRM | Defibrillator, Implantable, Dual-Chamber | FDA class 3 | Unknown |