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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
PMA NumberP860004
Supplement NumberS241
Date Received10/21/2015
Decision Date11/19/2015
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 Yes
Approval Order Statement 
To move the gear cutting process for the synchromed ii motor gears and pumphead gear (gears 1, 2, and 3 and pump head gear used in the motor design approved under p860004/s17) from hajime to seiko where the motor gears are currently manufactured.