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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 SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP SYSTEM
Classification Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS087
Date Received05/17/2006
Decision Date11/22/2006
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the electrical test specifications of the model 8637 pump.
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