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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameimplantable pulse generator, pacemaker (non-crt)
PMA NumberP010015
Date Received03/02/2001
Decision Date08/28/2001
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 01M-0373
Notice Date 08/30/2001
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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