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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 STARFIX MODEL 4195
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP060039
Supplement NumberS016
Date Received08/23/2010
Decision Date01/13/2011
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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