Programmer, Pacemaker
Basic Information
- Device Name
- Programmer, Pacemaker
- Trade Name
- VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR
- PMA Number
- P830045
- Supplement Number
- S090
- Device Class
- FDA Class 3
- Product Code
- KRG
- Generic Name
- Programmer, pacemaker
- Regulation Number
- 870.3700
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 30, 2004
- Date Received
- December 2, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO MODIFY THE HEADER DESIGN OF A CURRENTLY MARKETED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERITY ADX XL VDR MODEL 5456I AND IS INDICATED AS FOLLOWS: THE VERITY ADX XL VDR MODEL 5456I IS INDICATED FOR USE ONLY WITH AV PLUS MODEL 1328C OR 1358C SINGLE-PASS IN-LINE QUADRIPOLAR LEADS (THE VERITY ADX XL VDR PACING SYSTEM). THE VERITY ADX XL VDR PACING SYSTEM IS INTENDED TO PROVIDE VDD OR VDDR PACING FOR PATIENTS WITH A HEALTHY SINUS NODE AND AV CONDUCTION ABNORMALITIES. THESE MODES ARE INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT. THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN: A) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT, AND B) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED. ADDITIONAL INDICATIONS INCLUDE NORMAL SINUS RHYTHM AND NORMAL AV CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING.
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 |
|---|---|---|---|
| KRG | Programmer, Pacemaker | FDA class 3 | Cardiovascular |