Implantable Cardioverter Defibrillator (Non-Crt)
Basic Information
- Device Name
- Implantable Cardioverter Defibrillator (Non-Crt)
- Trade Name
- PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)
- PMA Number
- P910023
- Supplement Number
- S053
- 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
- July 18, 2001
- Date Received
- June 28, 2001
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE USE OF A NEW BATTERY MODEL (WGL 2150) FOR THE LEGALLY MARKETED ST. JUDE MEPRO MD (MODELS V-186F AND V-1 DR (MODEL V-230HV) AND P 5 VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-194 AND V-232). IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL FOR THE USE OF AN ALTERNATE IS-1 RECEPTACLE PLUG, MODEL AC-IP-2, FOR TH 5 DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE MD (MODELS V-186F AND V-1 DR (MODEL V-230HV) IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND ARE 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, THESE PULSE GENERATORS CAN BE USED IN PATIENTS WHOSE PRIMARY THERAPY FOR HEMODYNAMICALLY SIGNIFICANT, SUSTAINED VENTRICULAR TACHYCARDIA IS ANTI-TACHYCARDIA PACING; THE DEFIBRILLATION CAPABILITIES OF THESE DEVICES PROVIDE HIGH-ENERGY THERAPY IN THE EVENT THAT THE ARRHYTHMIA ACCELERATES. THE PULSE GENERATORS CAN BE IMPLANTED IN EITHER THE PECTORAL REGION OR THE ABDOMINAL REGION, AT THE PHYSICIAN'S DISCRETION. THE PHOTON 5 VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-194 AND V-232) ARE INTENDED TO PROVIDE VENTRICULAR ANTI-TACHYCARDIA 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 |