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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameauto implantable pacer cardioverter defib system
PMA NumberP940024
Date Received07/08/1994
Decision Date07/03/1997
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 97M-0500
Notice Date 12/18/1997
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the guardian(tm) atp ii model 4211 implantable cardioverter/defibrillator system. The guardian(tm) atp ii model 4211 implantable cardioverter defibrillator hereafter referred to as the 4211 implantable cardioverter defibrillator system consists of the following: the guardian(tm) atp ii model 4211 implantable cardioverter defbrillator; implantable defibrillator patch lead model 040-105, 040-106, 040-107, 040-128, 040-129 and 040-130; model 4510 implant support device; generic 4211 personality modeule; and system accessories (adapter models 040-051, 040-052, 040-047, 040-055, 033-330, and 033-320, model 042-018 patient interface module, model 040-021, stylet kit and cable models 042-010, 042-011, 042-015, 042-238 and 042-017). The 4211 system is indicated for use in patients who are at high risk of sudden death due to ventricular fibrillation and/or ventricular tachyrhythmias and who have experienced one of the following situation: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to ventricular tachyrhythmia or recurrent, poorly tolerated sustained ventricular tachycardia (vt). Note:the clinical outcome for hemodynamically stable, sustained-vt patients is not fully known. Safety and effectiveness studies have not been conducted.