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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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
ms mvs11
mounds view, MN 55112
PMA NumberP980016
Supplement NumberS056
Date Received09/16/2005
Decision Date10/20/2005
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.
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