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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.
 
Trade NameINSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS005
Date Received03/04/2002
Decision Date02/25/2003
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the insync iii model 8042 and insync iii model 9981 application software which is indicated as follows: the insync iii model 8042 device is indicated for the reduction of symptoms of moderate to severe heart failure (nyha class iii or iv), in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction <=35%, and a qrs >=130 ms. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increase in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of av synchrony.
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