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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 LEFT VENTRICULAR PACING LEAD, ATTAIN BIPOLAR OTW MODEL 4194
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP010015
Supplement NumberS012
Date Received02/09/2004
Decision Date08/20/2004
Product Code LWP 
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 MODIFICATION TO THE COIL AND INNER LUMEN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATTAIN BIPOLAR OTW MODEL 4194 AND IS INDICATED FOR USE AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.
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