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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceBOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS230
Date Received12/11/2009
Decision Date09/16/2010
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 11M-0034
Notice Date 01/25/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00180271
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE FOR THE COGNIS CRT-D MODELS N118, N119; LIVIANCRT-D MODELS H220, H225, H227 AND H229; AND CONTAK RENEWAL 3 RF HE CRT-D MODELSH210, H215, H217, H219 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) AS FOLLOWS:THESE BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INDICATED FOR PATIENTS WITH HEART FAILURE WHO RECEIVE STABLE OPTIMAL PHARMACOLOGIC THERAPY (OPT) FOR HEART FAILURE AND WHO MEET ANY ONE OF THE FOLLOWING CLASSIFICATIONS:1) MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III-IV) WITH EF <= 35% AND QRS DURATION>= 120 MS; OR2) LEFT BUNDLE BRANCH BLOCK (LBBB) WITH QRS >= 130 MS, EF <= 30%, AND MILD (NYHACLASS II) ISCHEMIC OR NONISCHEMIC HEART FAILURE OR ASYMPTOMATIC (NYHA CLASS I)ISCHEMIC HEART FAILURE.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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