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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.
 
DeviceBELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS015
Date Received03/18/2005
Decision Date06/22/2005
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE IMPLANT CONTROL SYSTEM (ICS) 3000 PROGRAMMING SYSTEM, USING SOFTWARE VERSION 501.U FOR USE WITH THE BELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS.
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