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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.
 
DevicePREVAIL
Generic NamePulse-generator, single chamber, sensor driven, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP850051
Supplement NumberS068
Date Received07/28/2008
Decision Date11/21/2008
Product Code LWO 
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
Approval Order Statement  
APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE. UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
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