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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.
 
DeviceVERSATRAX PACING SYSTEM
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP820003
Supplement NumberS117
Date Received11/29/2012
Decision Date05/30/2013
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE IMPLEMENTATION OF A DF-4 LEAD COMPATIBLE, CRIMPABLE ALLIGATOR CLIP ONTO THE SURGICAL CABLES, PROCESS IMPROVEMENTS FOR THE SPLICE YOKE OF THE CABLES AND A CHANGE TO THE WIRE GAUGES USED IN THE 2292 CABLE ASSEMBLY.
Approval OrderApproval Order
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