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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 NameATTAIN STARFIX LEAD
Classification Namepermanent defibrillator electrodes
Applicant MEDTRONIC INC.
PMA NumberP060039
Supplement NumberS001
Date Received07/09/2008
Decision Date08/08/2008
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in the following areas: 1) a change in the chart recorder to monitor the sterilization process; 2) a change in ethylene oxide (eo) sterilization exposure time; and 3) a change in the inspection method of the coating on the inner diameter of the tubing component.
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