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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.
 
DevicePROGRAMMER SOFTWARE A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATS
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS013
Date Received08/27/2004
Decision Date09/17/2004
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 USE OF THE PROGRAMMER SOFTWARE A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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