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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter defibrillator system
PMA NumberP000009
Date Received02/14/2000
Decision Date09/29/2000
Product Code
MRM[ Registered Establishments with MRM ]
Docket Number 01M-0042
Notice Date 01/23/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the phylax av icd system including the pulse generator, model number 122 382 and phylax av software cartridge swm 1000/i-gav. 2. U, model number 128 814. The device is indicated for use in patients who are at high risk of sudden death due to ventricular arrhythmias and have experienced one or more of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by a loss of consciousness due to a ventricular tachyarrhythmia 2) recurrent, poorly tolerated sustained ventricular tachycardia (vt) note: the clinical outcome for hemodynamically stable, sustained-vt patients id not fully known. Safety and effectiveness studies for this indication have not been conducted.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
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S038 S039 S040 S041 S042 S043 S045 S046 S047 
S048 S049 S050 S051 S052 S054 S055 S056 S057 
S058 S059