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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 NameCARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS014
Date Received03/10/2003
Decision Date05/14/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cardiac airbag and cardiac airbag-at and are intended to provide ventricular defibrillation for automated treatment of life-threatening arrhythmias in individuals not expected to have greater than 3 episodes of ventricular arrhythmias requiring icd therapy during the anticipated lifetime of the device.
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