Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Basic Information
- Device Name
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Trade Name
- PARADYM CRT-D MODEL 8750
- PMA Number
- P060027
- Supplement Number
- S015
- Device Class
- FDA Class 3
- Product Code
- NIK
- Generic Name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 7, 2010
- Date Received
- September 24, 2009
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE PARADYM VR MODEL 8250 AND DR MODEL 8550 WITH SMARTVIEW 2.18UG1 PROGRAMMER SOFTWARE AND THE PARADYM CRT-D MODEL 8750 WITH HARDWARE ANDMANUFACTURING CHANGES AND LABELING AND PROGRAMMER SOFTWARE CHANGES TO THE OVATIO VRMODEL 6250, DR MODEL 6550 AND CRT-D MODEL 6750. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PARADYM VR MODEL 8250 AND PARADYM DR MODEL 8550 WITHSMARTVIEW 2.18UG1 AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIACDEATH DUE TO VENTRICULAR TACHYARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWINGSITUATIONS: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST MANIFESTED BY THE LOSS OFCONSCIOUSNESS) DUE TO VENTRICULAR TACHYARRHYTHMIA, RECURRENT POORLY TOLERATED SUSTAINEDVENTRICULAR TACHYCARDIA.
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 |
|---|---|---|---|
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | FDA class 3 | Unknown |