PMA P830045S081

Device: ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S081
Product code: KRG
Decision date: 2002-07-30
Classification: Cardiovascular
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR A DOWNSIZED VERSION OF THE PHOTON UDR/VR DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V235) AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

Current openFDA PMA Record#

Device: ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S081
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2002-07-30
Decision code: APPR
Date received: 2002-07-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A DOWNSIZED VERSION OF THE PHOTON UDR/VR DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V235) AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.