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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 NamePHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS033
Date Received06/24/2003
Decision Date12/17/2003
Product Code
DXY[ Registered Establishments with DXY ]
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 modifications to home monitoring that will allow physicians to receive the implant data via the internet, email, fax or mobile phone. Home monitoring may be used with the following biotronik devices: philos dr-t, belos dr-t, belos vr-t, and cardiac airbag-t.
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