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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.
 
DevicePREMIER PACING SYSTEM
Generic NamePulse-generator, single chamber, sensor driven, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP850051
Supplement NumberS056
Date Received12/15/2000
Decision Date04/18/2001
Product Code LWO 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PREMIER PACING SYSTEM, INCLUDING THE PREMIER MODEL 8081 VVI PACEMAKER, THE CAPSURE MODEL 4003M ENDOCARDIAL LEAD AND THE MODEL 9884 SOFTWARE FOR THE MODEL 9790 AND 9790C PROGRAMMERS.
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