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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS033
Date Received05/21/2008
Decision Date06/09/2008
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MINOR MECHANICAL CHANGES TO THE ICS 3000 PROGRAMMER INCLUDING REMOVAL OF MAGNETS FROM THE PGH WAND AND REPLACEMENT OF AN EXISTING CONNECTOR AS WELL AS ASSOCIATED LABELING UPDATES.
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