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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 IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS042
Date Received02/26/1999
Decision Date03/18/1999
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of an alternate catheter port for use with the synchromed pump, model 8508 cap; addition of an application specific integrated circuit (asic) buffer chip to the pumps hybrid to improve battery longevity; addition of another suture loop to the shield; change in the device name from synchromed(tm) to synchromed el(tm); change in model numbers (new model numbers represent new synchromed el pumps); and change to labeling.
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