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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
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS063
Date Received10/19/2004
Decision Date11/12/2004
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Updating the final functional test software to reduce human data entry errors and adding an additional equipment interface to avoid calibration constant entry errors by manufacturing operators.
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