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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.
 
DeviceATTAIN PERFORMA MODEL 4398 AND 4598 LEFT VENTRICULAR LEADS
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant
MEDTRONIC Inc.
710 medtronic parkway ne
minneapolis, MN 55432
PMA NumberP080006
Supplement NumberS073
Date Received09/09/2014
Decision Date12/10/2014
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Clinical Trials NCT01751022
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 PERFORMATM LEFT VENTRICULAR LEADS (MODELS 4398 AND 4598), INDICATED FOR CHRONIC PACING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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