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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator,pacemaker programmer;icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS002
Date Received06/01/1999
Decision Date09/13/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for device hardware and software modifications. The device, as modified, will be marketed under the trade name mycrophylax(plus), phylax xm, and tms 1000(plus) tachyarrhythmia monitoring system. The devices are indicated for use in patients who are at risk of sudden death due to ventriular 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 tachyarrhythmias; or recurrent poorly tolerated sustained ventricular tachycardia (vt).
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