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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.
 
DeviceELLIPSE/FORTIFY ASSURA FAMILY OF ICDS
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS309
Date Received11/14/2012
Decision Date06/06/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.
Approval OrderApproval Order
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