|
Device | VENTAK AND CONTAK CD FAMILIES OF ICDS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S116 |
Date Received | 03/06/2006 |
Decision Date | 04/12/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |