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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.
 
Trade NamePHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Date Received06/08/1998
Decision Date10/27/1998
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 98M-0972
Notice Date 11/18/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the phylax implantable cardioverter defibrillator (icd) system: a) icd pulse generator - phylax xm icd, model number 121491; phylax xm active housing icd, model number 121492; phylax xm replacement icd, model number 121162 and mycrophylax icd, model number 121493; b) icd lead - sps 75 lead system, model number 120398; sl-icd lead systems (sl-icd 75/13, model number 120395, sl-icd 75/16, model number 120396, sl-icd 75/18, model number 120397, sl-icd 100/13, model number 116414, sl-icd 100/16, model number 118375, sl-icd118375, sl-icd 100/18, model number 119077); kainox sl lead systems (kainox sl 75/13, model number 124219, kainox sl 75/16, model number 124218, kainox sl 75/18, model number 124217, kainox sl 100/13, model number 124238, kainox sl 100/16, model number 124239, kainox sl 100/18, model number 124240); kainox rv 75 lead system, model number 124005; and (c) programming and monitoring system - tms 1000 tachyarrhythmia monitoring system, and software module swm 1000 f00i01. This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmia; or recurrent poorly tolerated sustained ventricular tachycardia (vt). Note: the clinical outcome for hemodynamically stable vt patients is not fully know. Safety and effectiveness studies for this indication have not been conducted.
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