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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 NameSYNCHROMED AND ISOMED IMPLANTABLE INFUSION PUMPS: MEDTRONIC MODEL 8840 N?VISION PROGRAMMING SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Namesynchromed & isomed implantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS083
Date Received05/15/2006
Decision Date07/05/2006
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the platform software on the model 8840 n'vision programming system.
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