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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 II IMPLANTABLE INFUSION PUMP MODEL 8637
Classification Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS094
Date Received10/18/2007
Decision Date01/16/2009
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design and manufacturing changes to the synchromed ii pump in regards to the pump head crew and pogo pin.
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