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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 NameMEDTRONIC LEFT VENTRICULAR PACING LEAD, ATTAIN BIPOLAR OTW MODEL 4194
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS012
Date Received02/09/2004
Decision Date08/20/2004
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modification to the coil and inner lumen. The device, as modified, will be marketed under the trade name attain bipolar otw model 4194 and is indicated for use as part of a medtronic biventricular pacing system.
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