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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.
 
DeviceSELECTED MODELS OF DUAL CHAMBER ICD DEVICES
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS021
Date Received10/12/2006
Decision Date01/30/2007
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 MINOR CHANGES TO THE RF CIRCUITRY IN THE LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND APPROVAL FOR UPDATED SOFTWARE VERSIONS TO CORRECT BRADYCARDIA AND TACHYCARDIA SOFTWARE ANOMALIES.
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