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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 ABILITY MODEL 4196 LEFT VENTRICULAR LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMedtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis, MN 55432
PMA NumberP080006
Supplement NumberS014
Date Received08/23/2010
Decision Date01/13/2011
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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