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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.
 
DeviceLEAD END CAP KIT / LEAD ADAPTOR SLEEVE KIT / UPSIZING SLEEVE KIT
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP900061
Supplement NumberS084
Date Received06/17/2009
Decision Date07/28/2009
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 FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
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