Implantable Pulse Generator, Pacemaker (Non-Crt)
Basic Information
- Device Name
- Implantable Pulse Generator, Pacemaker (Non-Crt)
- Trade Name
- VITALITY DS ICD SYSTEMS
- PMA Number
- P960040
- Supplement Number
- S031
- 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
- July 10, 2003
- Date Received
- March 17, 2003
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE VITALITY DS VR MODEL T135, VITALITY DS MODEL T125, AND VITALITY EL MODEL T127 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY DS VR MODEL T135, VITALITY DS MODEL T125, AND VITALITY EL MODEL T127 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6, AND THE INDICATION FOR USE IS AS FOLLOWS:GUIDANT ICDS ARE INTENDED TO PROVIDE THERAPY FOR THE AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE 1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR 2) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION OF <=30% (AS DEFINED IN APPENDIX E ).
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 |