Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Basic Information
- Device Name
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Trade Name
- MEDTRONIC INSYNC III MARQUIS,MAXIMO & SENTRY
- PMA Number
- P010031
- Supplement Number
- S018
- 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 8, 2005
- Date Received
- November 16, 2004
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE MEDTRONIC INSYNC III MARQUIS MODEL 7279 WITH MODEL 9989 APPLICATION SOFTWARE, MEDTRONIC INSYNC MAXIMO MODELS 7303 AND 7304 WITH MODEL 9998 APPLICATION SOFTWARE, MEDTRONIC INSYNC SENTRY MODELS 7297 AND 7299 WITH MODEL 9998 APPLICATION SOFTWARE. THE DEVICES ARE INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THIS SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION.
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 |