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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM
Generic Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP010015
Date Received03/02/2001
Decision Date08/28/2001
Product Code LWP 
Docket Number 01M-0373
Notice Date 08/30/2001
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM INCLUDING THE MODEL 8040 INSYNC PULSE GENERATOR, THE MODEL 9980 PROGRAMMER SOFTWARE, AND THE ATTAIN LV MODEL 2187 AND ATTAIN CS MODEL 2188 LEADS. THE PULSE GENERATOR AND LEADS ARE INDICATED AS FOLLOWS: 1) THE INSYNC MODEL 8040 PULSE GENERATOR IS INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SECERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL, MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A QRS DURATION = 130 MS. 2) THE ATTAIN LV MODEL 2187 LEAD HAS APPLICATION AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM. 3) THE ATTAIN CS MODEL 2188 LEAD HAS APPLICATION WHERE PERMANENT ATRIAL, OR FUAL-CHAMBER PACING SYSTEMS ARE INDICATED, OR AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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