Implantable Pulse Generator, Pacemaker (Non-Crt)
Basic Information
- Device Name
- Implantable Pulse Generator, Pacemaker (Non-Crt)
- Trade Name
- VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2
- PMA Number
- P960040
- Supplement Number
- S035
- Device Class
- FDA Class 3
- Product Code
- LWP
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 6, 2003
- Date Received
- September 11, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A FAST-CHARGE VERSION OF THE DEVICE (MODEL A155) AND TO CORRECT SOFTWARE ANOMALIES (MODELS A155 AND A135). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VENTAK VITALITY AVT AICD SYSTEM AND IS INDICATED AS FOLLOWS: THE VITALITY AVT AICD SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE ICD INDICATED AND WHO HAVE ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS; OR, PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <=30%.
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 |
|---|---|---|---|
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA class 3 | Unknown |