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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.
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
PMA NumberP080006
Supplement NumberS004
Date Received10/19/2009
Decision Date03/31/2011
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Clinical Trials NCT00853593
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for the attain ability straight model 4396 left ventricular lead. The model 4396 lead is a 4 french, transvenous, steroid eluting, dual electrode, polyurethane insulated, single coil, straight tip, tine fixation lead intended for use in left heart coronary veins.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress