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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.
 
DeviceMODEL 4195 ATTAIN STARFIX LEAD
Generic NamePermanent defibrillator electrodes
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP060039
Supplement NumberS021
Date Received01/26/2011
Decision Date11/22/2011
Product Codes NVY OJX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE REQUIREMENT FOR THE COPPER CONTENT IN THE BLUE POLYURETHANE TUBING UTILIZED BY THE MEDTRONIC ATTAIN STARFIX LEAD FROM 200 PPM TO 300 PPM.
Approval OrderApproval Order
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