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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.
 
DeviceINSYNC/INSYNC II CRT-IPG'S
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP010015
Supplement NumberS021
Date Received02/14/2006
Decision Date03/31/2006
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS. IT IS TO ENHANCE INTERNAL
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