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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 NameISOMED PUMP AND INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS011
Date Received07/24/2008
Decision Date10/17/2008
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the implementation of the sterilization automated release or star system to the sterilization operation at the medtronic neuromodulation sullivan lake manufacturing facility.
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