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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 MODEL 4196 LEAD; ATTAIN ABILITY PLUS MRI SURESCAN LEAD MODEL 4296; ATTAIN ABILITY STRAIGHT MRI
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMedtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis, MN 55432
PMA NumberP080006
Supplement NumberS093
Date Received05/03/2016
Decision Date10/25/2016
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
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