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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 ATTAIN OTW LV LEAD MODEL 4193
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 NumberS030
Date Received06/27/2007
Decision Date02/14/2008
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO ADD AN UPDATED VERSION OF THE POST-APPROVAL STUDY SUMMARY FOR THE ATTAIN OTW LV LEAD MODEL 4193 TO THE DEVICE LABELING.
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