Implantable Cardioverter Defibrillator (Non-Crt)
Basic Information
- Device Name
- Implantable Cardioverter Defibrillator (Non-Crt)
- Trade Name
- CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM
- PMA Number
- P910023
- Supplement Number
- S047
- 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
- October 27, 2000
- Date Received
- June 14, 2000
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 01M-0041
Advisory Committee Statement
APPROVAL FOR THE PHOTON(TM) DR ICD SYSTEM PROGRAMMER SOFTWARE, MODEL AC-IP IS-1 RECEPTABLE PLUG, AND MODEL 442-2 TORQUE DRIVER/TORQUE WRENCH. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A HISTORY OF HEMODYNAMICALLY COMPROMISING VENTRICULAR TACHYARRHYTHMIAS. THESE PATIENTS MAY HAVE EXPERIENCED A CARDIAC ARREST NOT ASSOCIATED WITH ACUTE MYOCARDIAL INFARCTION OR HAVE VENTRICULAR TACHYARRHYTHMIAS. IN ADDITION, THE PULSE GENERATOR CAN BE USED IN PATIENTS WHOSE PRIMARY THERAPY FOR HEMODYNAMICALLY SIGNIFICANT, SUSTAINED VENTRICULAR TACHYCARDIA IS ANTITACHYCARDIA PACING; THE DEFIBRILLATION CAPABILITIES OF THE DEVICE PROVIDE HIGH-ENERGY THERAPY IN THE EVENT THAT THE ARRHYTHMIA ACCELERATES. THE PULSE GENERATOR CAN BE IMPLANTED IN EITHER THE PECTORAL REGION OR THE ABDOMINAL REGION, AT THE PHYSICIAN'S DISCRETION.
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 |