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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 NameMEDTRONIC ATTAIN STARFIX LEAD MODEL 4195
Classification Namepermanent defibrillator electrodes
Applicant MEDTRONIC INC.
PMA NumberP060039
Supplement NumberS008
Date Received10/26/2009
Decision Date12/22/2009
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval of the post-approval study protocol.
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