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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLEAD END CAP KIT / LEAD ADAPTOR SLEEVE KIT / UPSIZING SLEEVE KIT
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
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 - other
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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