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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.
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
7000 central avenue ne
minneapolis, MN 55432-3576
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/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
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.