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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.
 
DeviceMICRONY FAMILY PACEMAKERS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP970013
Supplement NumberS054
Date Received11/14/2012
Decision Date06/06/2013
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
PPROVAL 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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