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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.
 
DeviceIMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS043
Date Received12/13/2010
Decision Date02/11/2011
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 ICS 3000 PROGRAMMER APPLICATION SOFTWARE VERSION PSW 1004.U, AND THE ESTELLA DR; ESTELLA DR-T; ESTELLA SR; ESTELLA SR-T; ECURO DR; ECURO DR-T; ECURO SR; ECURO SR-T; EFFECTA D; EFFECTA DR; EFFECTA S; AND EFFECTA SR. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES LISTED ABOVE, AND IS INDICATED FOR THE APPROVED INDICATION FOR USE.
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