PMA P830045S090

Device: VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S090
Product code: KRG
Decision date: 2004-01-30
Classification: Cardiovascular
Generic name: Programmer, pacemaker
Approval order 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.

Current openFDA PMA Record#

Device: VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S090
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2004-01-30
Decision code: APPR
Date received: 2003-12-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.