Implantable Pacemaker Pulse-Generator
Basic Information
- Device Name
- Implantable Pacemaker Pulse-Generator
- Trade Name
- VITATRON DA+ C SERIES PULSE GENERATORS
- PMA Number
- P990001
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- DXY
- Generic Name
- implantable pacemaker Pulse-generator
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 16, 2003
- Date Received
- February 20, 2003
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO RATE RESPONSE FEATURES, ADDITION OF TELEMETRY B, AND OTHER DIAGNOSTIC ENHANCEMENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/VITATRON DA+ C-SERIES IMPLANTABLE GENERATORS AND IS INDICATED AS FOLLOWS: 1) DUAL CHAMBER PACING IS INDICATED IF AV SYNCHRONY NEEDS TO BE RESTORED IN ORDER TO OPTIMIZE CARDIAC OUTPUT. FOR EXAMPLE, PATIENTS WITH SYMPTOMATIC SECOND OR THIRD DEGREE AV BLOCK. 2) DUAL CHAMBER RATE RESPONSIVE PACING MODES ARE OF SPECIFIC BENEFIT TO PATIENTS WITH CHRONOTROPIC INCOMPETENCE OF THE SINUS NODE. 3) RATE RESPONSIVE MODES CAN HELP PATIENTS WHO HAVE A REQUIREMENT FOR ANINCREASE IN PACING RATE IN RESPONSE TO PHYSICAL ACTIVITY. 4) SINGLE CHAMBER VENTRICULAR PACING CAN HELP PATIENTS WITH PERMANENT ATRIALTACHYARRHYTHMIAS, INCLUDING ATRIAL FIBRILLATION AND FLUTTER. 5) SINGLE CHAMBER ATRIAL PACING CAN HELP PATIENTS WITH SYMPTOMATIC BRADYARRHYTHMIASAND NORMAL AV CONDUCTION.
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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |