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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432
PMA NumberP080006
Supplement NumberS004
Date Received10/19/2009
Decision Date03/31/2011
Product Code OJX 
Advisory Committee Cardiovascular
Clinical TrialsNCT00853593
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Review MemoReview 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 OrderApproval Order
Post-Approval StudyShow Report Schedule and Study Progress
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