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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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator,pacemaker programmer;icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS003
Date Received11/02/1999
Decision Date05/01/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) the introduction of patient data manager softward, pdm 2000, and 2) a new method for determining the use before date of biotronik's icds.
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