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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.
 
DeviceDUAL CHAMBER, IMPLANTABLE PULSE GENERATOR
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 NumberS091
Date Received03/02/2009
Decision Date05/21/2009
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
Approval Order Statement  
APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
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