Implantable Cardioverter Defibrillator (Non-Crt)
Basic Information
- Device Name
- Implantable Cardioverter Defibrillator (Non-Crt)
- Trade Name
- MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH
- PMA Number
- P980016
- Supplement Number
- S029
- Device Class
- FDA Class 3
- Product Code
- LWS
- Generic Name
- Implantable cardioverter defibrillator (non-CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 17, 2002
- Date Received
- June 28, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS WITH MODEL 9967 (MARQUIS VR) APPLICATION SOFTWARE FOR USE WITH THE COMMERCIALLY AVAILABLE MODEL 9322 PATIENT MAGNET, THE MODEL 9790C PROGRAMMING SYSTEM [9790C PROGRAMMER, MODEL 9990 DESKTOP SOFTWARE AND MODEL 9767/9767L TELEMETRY PROGRAMMING HEAD (TELEMETRY B)] AND WITH THE MODEL 2090 PROGRAMMING SYSTEM [2090 PROGRAMMER, MODEL 9986 DESKTOP SOFTWARE AND MODEL 2067/2067L TELEMETRY PROGRAMMING HEAD (TELEMETRY PROGRAMMING HEAD (TELEMETRY B)]. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
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 |
|---|---|---|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | FDA class 3 | Unknown |