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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 NameMODEL 4195 ATTAIN STARFIX LEAD
Classification Namepermanent defibrillator electrodes
Applicant MEDTRONIC INC.
PMA NumberP060039
Supplement NumberS021
Date Received01/26/2011
Decision Date11/22/2011
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review 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 Order Approval Order
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