PMA P010012S116

Device: VENTAK AND CONTAK CD FAMILIES OF ICDS
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S116
Product code: LWP
Decision date: 2006-04-12
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE VENTAK (P960040) AND CONTAK CD (P010012) FAMILIES OF IMPLANTABLE DEFIBRILLATORS TO INCLUDE INFORMATION REGARDING BEHAVIOR OF THESE DEVICES ATTRIBUTABLE TO THE SVO (SILVER VANADIUM OXIDE) USED TO POWER THEM. SPECIFICALLY, AN UPDATE TO THE SYSTEM GUIDE TO INCLUDE LANGUAGE TO IDENTIFY AS NORMAL AN INCREASED CHARGED TIME IN MIDLIFE DUE TO THE INHERENT CHARACTERISTICS OF THE SVO BATTERIES USED.

Current openFDA PMA Record#

Device: VENTAK AND CONTAK CD FAMILIES OF ICDS
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S116
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2006-04-12
Decision code: APPR
Date received: 2006-03-06
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE VENTAK (P960040) AND CONTAK CD (P010012) FAMILIES OF IMPLANTABLE DEFIBRILLATORS TO INCLUDE INFORMATION REGARDING BEHAVIOR OF THESE DEVICES ATTRIBUTABLE TO THE SVO (SILVER VANADIUM OXIDE) USED TO POWER THEM. SPECIFICALLY, AN UPDATE TO THE SYSTEM GUIDE TO INCLUDE LANGUAGE TO IDENTIFY AS NORMAL AN INCREASED CHARGED TIME IN MIDLIFE DUE TO THE INHERENT CHARACTERISTICS OF THE SVO BATTERIES USED.